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    Clinical Trial Results:
    A Study of Liposomal Doxorubicin With or Without Olaratumab (IMC-3G3) in Platinum-Refractory or Resistant Advanced Ovarian Cancer

    Summary
    EudraCT number
    		 2009-009035-30
    Trial protocol
    		 GB  
    Global end of trial date
    13 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Dec 2016
    First version publication date
    04 Dec 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    13899
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00913835
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 13899, Trial Alias: I5B-IE-JGDA
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company , 1 877-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company , 1 877-285-4559,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine if participants with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal Doxorubicin alone.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jun 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 75
    Country: Number of subjects enrolled
    United Kingdom: 31
    Country: Number of subjects enrolled
    Spain: 19
    Worldwide total number of subjects
    125
    EEA total number of subjects
    50
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    90
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Entered

    Pre-assignment
    Screening details
    		 Participants from liposomal doxorubicin (Lip Dox) treatment group who had progressive disease (PD) had the option to receive to Olaratumab (Olara) monotherapy. Participants who had evidence of PD, died in either period, or received optional Olaratumab monotherapy from liposomal doxorubicin monotherapy were considered to have completed the study.

    Period 1
    Period 1 title
    Olara+Lip Dox and Lip Dox Monotherapy
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Olaratumab + Liposomal Doxorubicin
    Arm description
    		 20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity. 40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    IMC-3G3, LY3012207
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.

    Investigational medicinal product name
    Liposomal Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.

    Arm title
    		 Liposomal Doxorubicin
    Arm description
    		 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Liposomal Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m² of liposomal doxorubicin was administered according to the manufacturer's instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks.

    Number of subjects in period 1
    		Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin
    Started
    63
    62
    Received Any Study Drug
    62
    61
    Completed
    55
    55
    Not completed
    8
    7
         Consent withdrawn by subject
    2
    3
         Not Specified
    4
    3
         Lost to follow-up
    1
    -
         Off Study Treatment/Alive
    1
    1
    Period 2
    Period 2 title
    Lip Dox: Olaratumab Monotherapy
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Optional Olaratumab Monotherapy
    Arm description
    		 20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olaratumab
    Investigational medicinal product code
    Other name
    IMC-3G3, LY3012207
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.

    Number of subjects in period 2 [1]
    		Optional Olaratumab Monotherapy
    Started
    28
    Received at least 1 dose of study drug
    28
    Completed
    25
    Not completed
    3
         Not Specified
    3
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants from liposomal doxorubicin (Lip Dox) treatment group who had progressive disease (PD) had the option to receive to Olaratumab (Olara) monotherapy.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olaratumab + Liposomal Doxorubicin
    Reporting group description
    		 20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity. 40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.

    Reporting group title
    Liposomal Doxorubicin
    Reporting group description
    		 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.

    Reporting group values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin Total
    Number of subjects
    		 63 62 125
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 47 43 90
        From 65-84 years
    		 16 19 35
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.7 ± 10.07 59.8 ± 9.7 -
    Gender, Male/Female
    Units: participants
        Female
    		 63 62 125
        Male
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 6 7
        Not Hispanic or Latino
    		 62 55 117
        Unknown or Not Reported
    		 0 1 1
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 1 3 4
        Black or African American
    		 5 1 6
        Native Hawaiian of Other Pacific Islander
    		 0 1 1
        White
    		 55 55 110
        Other
    		 2 2 4
    Region of Enrollment
    Units: Subjects
        United States
    		 41 34 75
        United Kingdom
    		 17 14 31
        Spain
    		 5 14 19
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    ECOG PS classified participants according to their functional impairment.
    Units: Subjects
        0-Fully Active
    		 38 32 70
        1-ambulatory, able to do light/sedentary nature
    		 25 30 55
    Stratification Factor
    Participants reaction to prior platinum treatment.
    Units: Subjects
        Platinum Refractory
    		 16 15 31
        Platinum Resistant
    		 47 47 94

    End points

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    End points reporting groups
    Reporting group title
    Olaratumab + Liposomal Doxorubicin
    Reporting group description
    		 20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity. 40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.

    Reporting group title
    Liposomal Doxorubicin
    Reporting group description
    		 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
    Reporting group title
    Optional Olaratumab Monotherapy
    Reporting group description
    		 20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.

    Subject analysis set title
    Olaratumab and Liposomal Doxorubicin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.

    Subject analysis set title
    Olaratumab and Liposomal Doxorubicin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.

    Subject analysis set title
    Olaratumab and Liposomal Doxorubicin
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks. 40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity.

    Primary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
    End point type
    Primary
    End point timeframe
    Randomization to Progressive Disease (PD) or Date of Death (Up to 35 Months)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin
    Number of subjects analysed
    62 [1]
    61 [2]
    Units: weeks
        median (confidence interval 90%)
    18.1 (8.7 to 27)
    17.3 (14.1 to 31.9)
    Notes
    [1] - All randomized participants who received any amount of study drug. Censored participants: 13 and 14.
    [2] - All randomized participants who received any amount of study drug. Censored participants: 13 and 14.
    Statistical analysis title
    		 Progression Free Survival Statistical Analysis
    Statistical analysis description
    PFS is defined as the time from the day of randomization to the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) criteria or death from any cause. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
    Comparison groups
    Olaratumab + Liposomal Doxorubicin v Liposomal Doxorubicin
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8049 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.054
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.751
         upper limit
    		 1.478
    Notes
    [3] - Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the time from first day of therapy to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up, OS was censored on the last date the participant was known to be alive.
    End point type
    Secondary
    End point timeframe
    First Day of Therapy to Date of Death (Up to 35 Months)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin
    Number of subjects analysed
    62 [4]
    61
    Units: weeks
        median (confidence interval 90%)
    72.3 (52.4 to 86.7)
    70.6 (51.4 to 106.4)
    Notes
    [4] - All randomized participants who received any amount of study drug. Participants censored: 21 and 23
    Statistical analysis title
    		 Overall Survival Statistical Analysis
    Comparison groups
    Olaratumab + Liposomal Doxorubicin v Liposomal Doxorubicin
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6346 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.115
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.768
         upper limit
    		 1.618
    Notes
    [5] - Stratified by prior platinum treatment, platinum-refractory versus platinum-resistance reaction.

    Secondary: Percentage of Participants with Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

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    End point title
    		 Percentage of Participants with Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
    End point description
    The percentage of participants with a best overall response of confirmed CR or PR defined using RECIST v1.0 criteria. CR is the disappearance of all target and non-target lesions and normalization of cancer antigen-125 (CA-125) levels. PR is defined as having a ≥30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. The percentage of participants with objective response was calculated as: (number of participants whose best overall response of CR or PR/number of participants treated) * 100.
    End point type
    Secondary
    End point timeframe
    Randomization to PD (Up to 35 Months)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin
    Number of subjects analysed
    62 [6]
    61
    Units: percentage of participants
        number (confidence interval 90%)
    12.9 (6.6 to 22.1)
    16.4 (9.2 to 26.2)
    Notes
    [6] - All randomized participants who received any amount of study drug.
    Statistical analysis title
    		 Objective Response Rate (ORR) Statistical Analysis
    Comparison groups
    Olaratumab + Liposomal Doxorubicin v Liposomal Doxorubicin
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.619
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Median Duration of Response

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    End point title
    		 Median Duration of Response
    End point description
    Duration of response is the interval from the date of initial CR or PR until the first date criteria for PD is met using RECIST v1.0 criteria, or initiation of other (or additional) antitumor therapy is first reported, or death due to any cause. CR is the disappearance of all target and non-target lesions and the normalization of tumor marker levels. PR is a ≥30% decrease in the sum of the LD of target lesions without new lesions and progression of non-target lesions. PD is a ≥20% increase in the sum of the LD of target lesions and/or unequivocal progression of existing non-target lesions and/or detection of 1 or more new lesions. Participants who did not relapse were censored on the day of their last tumor assessment.
    End point type
    Secondary
    End point timeframe
    Date of Initial CR or PR to PD (Up to 35 Months)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin
    Number of subjects analysed
    8 [7]
    10 [8]
    Units: weeks
        number (confidence interval 90%)
    39.1 (26.1 to 56.1)
    16.9 (15.3 to 9999)
    Notes
    [7] - All participants who achieved CR or PR. Participants censored: Olaratumab=2, Liposomal Doxorubicin=4
    [8] - 9999=N/A. Upper limit of confidence interval (CI) not estimable, did not reach the upper limit of CI
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs) and who died

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    End point title
    		 Number of Participants with Adverse Events (AEs) and who died
    End point description
    Reported are the number of participants with clinically significant events, defined as serious AEs (SAEs) and other non-serious AEs regardless of causality and those who died during treatment and during the 30-day post-dose follow-up.  A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module of this report.
    End point type
    Secondary
    End point timeframe
    Baseline Up to End of Treatment and 30-day Post-dose Follow-up (Up to 35 Months)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin
    Number of subjects analysed
    62 [9]
    61
    Units: participants
    number (not applicable)
        SAEs
    27
    23
        Other Non-SAEs
    62
    60
        Deaths on treatment or within 30 days of last dose
    2
    2
    Notes
    [9] - All randomized participants who received any amount of study drug.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Olaratumab Antibodies

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    End point title
    		 Percentage of Participants with Anti-Olaratumab Antibodies
    End point description
    Participants with Treatment Emergent (TE) anti-olaratumab antibodies were participants with a 4-fold increase (2 dilutions) increase over a positive baseline antibody titer or for a negative baseline titer, a participant with an increase from the baseline to a level of 1:20.
    End point type
    Secondary
    End point timeframe
    Baseline Up to 30-Day Postdose Follow-Up (Up To 35 Months)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin
    Number of subjects analysed
    57 [10]
    20 [11]
    Units: percentage of participants
        number (not applicable)
    1.8
    0
    Notes
    [10] - All randomized participants who received at least one dose of study drug and had evaluable data.
    [11] - All randomized participants who received at least one dose of study drug and had evaluable data.
    No statistical analyses for this end point

    Secondary: Area under the curve (AUC) of Olaratumab

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    End point title
    		 Area under the curve (AUC) of Olaratumab
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and 1 Hour (h) After Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin Optional Olaratumab Monotherapy
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    Units: number
        number (not applicable)
    Notes
    [12] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [13] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [14] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    No statistical analyses for this end point

    Secondary: PFS of Participants who Received Olaratumab after Liposomal Doxorubicin monotherapy (Descriptive statistics for safety and efficacy for participants who continue on Olaratumab monotherapy following disease progression on liposomal doxorubicin monotherapy)

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    End point title
    		 PFS of Participants who Received Olaratumab after Liposomal Doxorubicin monotherapy (Descriptive statistics for safety and efficacy for participants who continue on Olaratumab monotherapy following disease progression on liposomal doxorubicin monotherapy)
    End point description
    PFS is defined as the time from start of Olaratumab monotherapy to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment.
    End point type
    Secondary
    End point timeframe
    From Start of Olaratumab Monotherapy to PD or Date of Death (Up to 20 Weeks)
    End point values
    		 Optional Olaratumab Monotherapy
    Number of subjects analysed
    28
    Units: weeks
        median (confidence interval 90%)
    7.7 (7.1 to 10.4)
    No statistical analyses for this end point

    Secondary: Maximum Concentration (Cmax) of Olaratumab

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    End point title
    		 Maximum Concentration (Cmax) of Olaratumab
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin Optional Olaratumab Monotherapy
    Number of subjects analysed
    0 [15]
    0 [16]
    0 [17]
    Units: number
        number (not applicable)
    Notes
    [15] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [16] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [17] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    No statistical analyses for this end point

    Secondary: Half-life (t1/2) of Olaratumab

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    End point title
    		 Half-life (t1/2) of Olaratumab
    End point description
    The time it takes to reduce the concentration of Olaratumab in the plasma by 50%.
    End point type
    Secondary
    End point timeframe
    Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin Optional Olaratumab Monotherapy
    Number of subjects analysed
    0 [18]
    0 [19]
    0 [20]
    Units: number
        number (not applicable)
    Notes
    [18] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [19] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [20] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    No statistical analyses for this end point

    Secondary: Clearance (CL) of Olaratumab

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    End point title
    		 Clearance (CL) of Olaratumab
    End point description
    CL is the volume of serum cleared of Olaratumab per unit of time after a single dose of Olaratumab
    End point type
    Secondary
    End point timeframe
    Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin Optional Olaratumab Monotherapy
    Number of subjects analysed
    0 [21]
    0 [22]
    0 [23]
    Units: number
        number (not applicable)
    Notes
    [21] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [22] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [23] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    No statistical analyses for this end point

    Secondary: Apparent Volume of distribution (Vss) of Olaratumab

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    End point title
    		 Apparent Volume of distribution (Vss) of Olaratumab
    End point description
    Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
    End point type
    Secondary
    End point timeframe
    Prior to and 1 h after Olaratumab Infusion in Cycles 1, 2, and 4 and 48 h or 72 h, 144 h, 240 h or 264 h and 336 h Post-dose in Cycles 1 and 4 (28-day Cycles)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin Optional Olaratumab Monotherapy
    Number of subjects analysed
    0 [24]
    0 [25]
    0 [26]
    Units: number
        number (not applicable)
    Notes
    [24] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [25] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    [26] - Zero participants were analyzed. Due to technical reasons not related to safety or efficacy.
    No statistical analyses for this end point

    Secondary: PFS for Participants who had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association between PDGFRα tumor expression and PFS)

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    End point title
    		 PFS for Participants who had Tissue Samples for Platelet Derived Growth Factor Receptor Alpha (PDGFRα) Expression Determined by Immunohistochemistry (IHC) (Association between PDGFRα tumor expression and PFS)
    End point description
    PFS is defined as the time from the day of randomization to the first evidence of progression as defined by RECIST v1.0 criteria or death from any cause. Participants who died without a reported prior disease progression were considered to have progressed on the day of their death. Participants who did not progress and were subsequently lost to follow-up had their data censored at the day of last tumor assessment. PDGFRα protein expression at baseline in tumor cells is determined by IHC using H-Scores and a cut point of 0. Participants were considered to have a high relative expression when H-Score is >0 and a low relative expression when H-Score=0. H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining. Staining intensity: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from 0-300.
    End point type
    Secondary
    End point timeframe
    Randomization to PD or Date of Death (Up to 130 Weeks)
    End point values
    		 Olaratumab + Liposomal Doxorubicin Liposomal Doxorubicin
    Number of subjects analysed
    54 [27]
    47
    Units: weeks
    median (confidence interval 95%)
        High Expression (n=41, 36)
    21 (8.7 to 34.1)
    17.3 (12.3 to 33.9)
        Low Expression (n=13,11)
    32.7 (7.6 to 41.3)
    24 (8.1 to 36.1)
    Notes
    [27] - All participants who had evaluable PDGFRα results.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    I5B-IE-JGDA
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Olaratumab + Liposomal Doxorubicin
    Reporting group description
    		 -

    Reporting group title
    Optional Olaratumab Monotherapy
    Reporting group description
    		 -

    Reporting group title
    Liposomal Doxorubicin
    Reporting group description
    		 -

    Serious adverse events
    		 Olaratumab + Liposomal Doxorubicin Optional Olaratumab Monotherapy Liposomal Doxorubicin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 62 (43.55%)
    14 / 28 (50.00%)
    23 / 61 (37.70%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    venous thrombosis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    chills
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    disease progression
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    extravasation
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    infusion site erythema
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    mucosal inflammation
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 28 (7.14%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    hypersensitivity
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    interstitial lung disease
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 28 (0.00%)
    4 / 61 (6.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    bradyphrenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    femur fracture
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    incorrect drug administration duration
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    medication error
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    pyloric stenosis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    cardiac failure congestive
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    coronary artery stenosis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    haemorrhage intracranial
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 28 (3.57%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    abdominal distension
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 28 (0.00%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    abdominal pain
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    3 / 61 (4.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    3 / 61 (4.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    constipation
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    duodenal stenosis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal obstruction
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ileus
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 28 (3.57%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 28 (7.14%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    proctitis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    rectal haemorrhage
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    4 / 61 (6.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 28 (7.14%)
    3 / 61 (4.92%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    bile duct obstruction
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    hydronephrosis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    1 / 28 (3.57%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    renal failure
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    renal failure acute
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    flank pain
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bacillus infection
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    febrile infection
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    infection
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pharyngitis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection fungal
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    viral infection
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Olaratumab + Liposomal Doxorubicin Optional Olaratumab Monotherapy Liposomal Doxorubicin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    62 / 62 (100.00%)
    27 / 28 (96.43%)
    60 / 61 (98.36%)
    Vascular disorders
    flushing
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    4
    0
    1
    hypertension
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    1 / 28 (3.57%)
    3 / 61 (4.92%)
         occurrences all number
    4
    1
    3
    hypotension
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    5
    0
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    8 / 62 (12.90%)
    4 / 28 (14.29%)
    11 / 61 (18.03%)
         occurrences all number
    11
    6
    21
    early satiety
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 28 (0.00%)
    4 / 61 (6.56%)
         occurrences all number
    3
    0
    4
    fatigue
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    33 / 62 (53.23%)
    5 / 28 (17.86%)
    27 / 61 (44.26%)
         occurrences all number
    64
    6
    50
    mucosal inflammation
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    12 / 62 (19.35%)
    2 / 28 (7.14%)
    15 / 61 (24.59%)
         occurrences all number
    19
    3
    38
    oedema peripheral
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 62 (16.13%)
    3 / 28 (10.71%)
    12 / 61 (19.67%)
         occurrences all number
    13
    3
    16
    pyrexia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    8 / 62 (12.90%)
    3 / 28 (10.71%)
    7 / 61 (11.48%)
         occurrences all number
    15
    3
    7
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 62 (16.13%)
    2 / 28 (7.14%)
    7 / 61 (11.48%)
         occurrences all number
    10
    2
    7
    dyspnoea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 62 (16.13%)
    4 / 28 (14.29%)
    10 / 61 (16.39%)
         occurrences all number
    11
    4
    12
    oropharyngeal pain
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 62 (8.06%)
    0 / 28 (0.00%)
    3 / 61 (4.92%)
         occurrences all number
    5
    0
    4
    pleural effusion
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    6 / 62 (9.68%)
    2 / 28 (7.14%)
    4 / 61 (6.56%)
         occurrences all number
    11
    3
    4
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 62 (11.29%)
    0 / 28 (0.00%)
    6 / 61 (9.84%)
         occurrences all number
    7
    0
    6
    insomnia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 62 (8.06%)
    1 / 28 (3.57%)
    3 / 61 (4.92%)
         occurrences all number
    5
    1
    3
    Investigations
    haemoglobin decreased
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 62 (11.29%)
    2 / 28 (7.14%)
    4 / 61 (6.56%)
         occurrences all number
    8
    3
    4
    neutrophil count decreased
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 28 (0.00%)
    5 / 61 (8.20%)
         occurrences all number
    6
    0
    5
    weight decreased
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    9 / 62 (14.52%)
    1 / 28 (3.57%)
    4 / 61 (6.56%)
         occurrences all number
    10
    1
    4
    white blood cell count decreased
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    6 / 62 (9.68%)
    0 / 28 (0.00%)
    3 / 61 (4.92%)
         occurrences all number
    27
    0
    3
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 62 (16.13%)
    1 / 28 (3.57%)
    10 / 61 (16.39%)
         occurrences all number
    12
    1
    13
    dysgeusia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 62 (16.13%)
    0 / 28 (0.00%)
    3 / 61 (4.92%)
         occurrences all number
    12
    0
    6
    headache
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    12 / 62 (19.35%)
    6 / 28 (21.43%)
    7 / 61 (11.48%)
         occurrences all number
    18
    7
    8
    lethargy
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    6 / 62 (9.68%)
    0 / 28 (0.00%)
    4 / 61 (6.56%)
         occurrences all number
    10
    0
    6
    neuropathy peripheral
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 62 (8.06%)
    0 / 28 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    6
    0
    4
    paraesthesia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 28 (0.00%)
    6 / 61 (9.84%)
         occurrences all number
    4
    0
    7
    tremor
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    4
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 62 (16.13%)
    6 / 28 (21.43%)
    13 / 61 (21.31%)
         occurrences all number
    21
    8
    23
    leukopenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    6 / 62 (9.68%)
    0 / 28 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    10
    0
    2
    lymphadenopathy
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    5
    0
    0
    neutropenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    16 / 62 (25.81%)
    2 / 28 (7.14%)
    8 / 61 (13.11%)
         occurrences all number
    67
    3
    23
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 28 (7.14%)
    3 / 61 (4.92%)
         occurrences all number
    1
    2
    3
    abdominal distension
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    14 / 62 (22.58%)
    5 / 28 (17.86%)
    6 / 61 (9.84%)
         occurrences all number
    18
    5
    8
    abdominal pain
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    15 / 62 (24.19%)
    3 / 28 (10.71%)
    25 / 61 (40.98%)
         occurrences all number
    22
    3
    35
    abdominal pain lower
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    2 / 28 (7.14%)
    5 / 61 (8.20%)
         occurrences all number
    4
    3
    6
    abdominal pain upper
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 62 (16.13%)
    2 / 28 (7.14%)
    7 / 61 (11.48%)
         occurrences all number
    11
    3
    8
    ascites
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    12 / 62 (19.35%)
    5 / 28 (17.86%)
    6 / 61 (9.84%)
         occurrences all number
    17
    6
    9
    constipation
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    32 / 62 (51.61%)
    7 / 28 (25.00%)
    24 / 61 (39.34%)
         occurrences all number
    40
    8
    33
    diarrhoea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    19 / 62 (30.65%)
    5 / 28 (17.86%)
    13 / 61 (21.31%)
         occurrences all number
    28
    5
    16
    dry mouth
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 62 (8.06%)
    0 / 28 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    5
    0
    1
    dyspepsia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    8 / 62 (12.90%)
    7 / 28 (25.00%)
    7 / 61 (11.48%)
         occurrences all number
    14
    7
    7
    dysphagia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 28 (0.00%)
    3 / 61 (4.92%)
         occurrences all number
    5
    0
    5
    flatulence
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 62 (3.23%)
    0 / 28 (0.00%)
    4 / 61 (6.56%)
         occurrences all number
    2
    0
    5
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 62 (11.29%)
    1 / 28 (3.57%)
    6 / 61 (9.84%)
         occurrences all number
    7
    1
    7
    nausea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    35 / 62 (56.45%)
    13 / 28 (46.43%)
    39 / 61 (63.93%)
         occurrences all number
    61
    16
    61
    odynophagia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    0 / 28 (0.00%)
    4 / 61 (6.56%)
         occurrences all number
    2
    0
    4
    stomatitis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    23 / 62 (37.10%)
    2 / 28 (7.14%)
    16 / 61 (26.23%)
         occurrences all number
    40
    2
    34
    vomiting
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    21 / 62 (33.87%)
    10 / 28 (35.71%)
    18 / 61 (29.51%)
         occurrences all number
    41
    12
    33
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 62 (16.13%)
    1 / 28 (3.57%)
    9 / 61 (14.75%)
         occurrences all number
    11
    1
    10
    blister
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 62 (11.29%)
    1 / 28 (3.57%)
    7 / 61 (11.48%)
         occurrences all number
    11
    1
    11
    dry skin
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    8 / 62 (12.90%)
    0 / 28 (0.00%)
    10 / 61 (16.39%)
         occurrences all number
    11
    0
    11
    erythema
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 62 (11.29%)
    0 / 28 (0.00%)
    8 / 61 (13.11%)
         occurrences all number
    7
    0
    10
    night sweats
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 28 (7.14%)
    0 / 61 (0.00%)
         occurrences all number
    0
    2
    0
    palmar-plantar erythrodysaesthesia syndrome
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    21 / 62 (33.87%)
    1 / 28 (3.57%)
    27 / 61 (44.26%)
         occurrences all number
    54
    2
    60
    pruritus
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    1 / 28 (3.57%)
    5 / 61 (8.20%)
         occurrences all number
    3
    1
    5
    rash
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    24 / 62 (38.71%)
    4 / 28 (14.29%)
    14 / 61 (22.95%)
         occurrences all number
    37
    5
    34
    skin discolouration
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 28 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    4
    0
    2
    skin hyperpigmentation
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    0 / 28 (0.00%)
    6 / 61 (9.84%)
         occurrences all number
    4
    0
    11
    Renal and urinary disorders
    hydronephrosis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 62 (1.61%)
    2 / 28 (7.14%)
    1 / 61 (1.64%)
         occurrences all number
    1
    3
    1
    pollakiuria
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 28 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    5
    0
    2
    proteinuria
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 62 (11.29%)
    1 / 28 (3.57%)
    2 / 61 (3.28%)
         occurrences all number
    10
    1
    2
    renal failure
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    2 / 28 (7.14%)
    0 / 61 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    11 / 62 (17.74%)
    1 / 28 (3.57%)
    7 / 61 (11.48%)
         occurrences all number
    13
    1
    8
    back pain
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    16 / 62 (25.81%)
    5 / 28 (17.86%)
    9 / 61 (14.75%)
         occurrences all number
    18
    6
    12
    muscle spasms
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 62 (11.29%)
    3 / 28 (10.71%)
    3 / 61 (4.92%)
         occurrences all number
    14
    3
    3
    musculoskeletal pain
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    1 / 28 (3.57%)
    0 / 61 (0.00%)
         occurrences all number
    4
    1
    0
    pain in extremity
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    1 / 28 (3.57%)
    9 / 61 (14.75%)
         occurrences all number
    5
    2
    9
    Infections and infestations
    candidiasis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 62 (6.45%)
    0 / 28 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    4
    0
    0
    oral candidiasis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 62 (3.23%)
    2 / 28 (7.14%)
    2 / 61 (3.28%)
         occurrences all number
    3
    2
    3
    upper respiratory tract infection
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 62 (4.84%)
    2 / 28 (7.14%)
    4 / 61 (6.56%)
         occurrences all number
    4
    2
    5
    urinary tract infection
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    15 / 62 (24.19%)
    3 / 28 (10.71%)
    3 / 61 (4.92%)
         occurrences all number
    23
    3
    5
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    15 / 62 (24.19%)
    10 / 28 (35.71%)
    13 / 61 (21.31%)
         occurrences all number
    31
    10
    19
    dehydration
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 62 (11.29%)
    1 / 28 (3.57%)
    2 / 61 (3.28%)
         occurrences all number
    7
    1
    2
    hyperglycaemia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    0 / 62 (0.00%)
    0 / 28 (0.00%)
    4 / 61 (6.56%)
         occurrences all number
    0
    0
    5
    hypokalaemia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 62 (8.06%)
    4 / 28 (14.29%)
    7 / 61 (11.48%)
         occurrences all number
    8
    5
    8
    hypomagnesaemia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    8 / 62 (12.90%)
    2 / 28 (7.14%)
    6 / 61 (9.84%)
         occurrences all number
    15
    3
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Mar 2010
    Protocol Version 2.0 dated 10-Mar-2010 Changes from Version 1.2 • This protocol is being amended primarily to incorporate new procedures in blood sampling for pharmacodynamic analyses. Additional changes to study procedures have been made and language regarding existing study procedures has been modified for the sake of clarity.
    13 Apr 2010
    Protocol Version 2.1 dated 13-Apr-2010 • This administrative amendment, Version 2.1, was instituted to make clear that all study procedures, with the exception of those performed every 8 weeks (ie, imaging studies/tumor assessments), are performed relative to treatment cycles, and not at fixed intervals. The actual (not planned) administration of each liposomal doxorubicin infusion will define Day 1 of each 28-day treatment cycle. Therefore, treatment delays, for whatever reason, will also cause an equivalent delay in all other study procedures (with the exception of imaging studies/tumor assessments). Language throughout Section 7, Study Activities, was clarified accordingly, and an additional sentence was added to Section 4, Investigational Plan, to provide a definition of “treatment cycle.”

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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