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    Clinical Trial Results:
    A Randomized, Open-Label Phase I/II Study Evaluating Ramucirumab in Pediatric Patients and Young Adults with relapsed, Recurrent, or Refractory Synovial Sarcoma.

    Summary
    EudraCT number
    		 2018-004243-23
    Trial protocol
    		 FR   DE   BE   ES   GB   IT  
    Global end of trial date
    23 Feb 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2023
    First version publication date
    08 Sep 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    J1S-MC-JV02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04145700
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17306
    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
    23 Feb 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory synovial sarcoma (SS) in children and young adults. This trial is part of the CAMPFIRE master protocol which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
    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
    04 Mar 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    United States: 5
    Worldwide total number of subjects
    23
    EEA total number of subjects
    8
    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)
    1
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Completers included participants who died from any cause.

    Pre-assignment
    Screening details
    		 No Text Available

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ramucirumab + Gemcitabine + Docetaxel
    Arm description
    		 Participants received intravenous infusions of ramucirumab 9 milligrams per kilogram (mg/kg), gemcitabine 900 milligrams per meter square (mg/m2) on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ramucirumab
    Investigational medicinal product code
    Other name
    LY3009806
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received intravenous infusion of ramucirumab 9 mg/kg on days 1, 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received intravenous infusion of gemcitabine 900 mg/m2 on days 1, 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received intravenous infusion of docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Arm title
    		 Gemcitabine + Docetaxel
    Arm description
    		 Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received intravenous infusion of gemcitabine 900 mg/m2 on days 1, 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received intravenous infusion of docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Number of subjects in period 1
    		Ramucirumab + Gemcitabine + Docetaxel Gemcitabine + Docetaxel
    Started
    16
    7
    Received at least one dose of study drug
    16
    6
    Completed
    8
    4
    Not completed
    8
    3
         Consent withdrawn by subject
    8
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ramucirumab + Gemcitabine + Docetaxel
    Reporting group description
    		 Participants received intravenous infusions of ramucirumab 9 milligrams per kilogram (mg/kg), gemcitabine 900 milligrams per meter square (mg/m2) on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Gemcitabine + Docetaxel
    Reporting group description
    		 Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group values
    		 Ramucirumab + Gemcitabine + Docetaxel Gemcitabine + Docetaxel Total
    Number of subjects
    		 16 7 23
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 17.70 ± 4.22 21.40 ± 4.58 -
    Gender categorical
    Units: Subjects
        Female
    		 6 4 10
        Male
    		 10 3 13
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 1 2
        Not Hispanic or Latino
    		 14 6 20
        Unknown or Not Reported
    		 1 0 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 2 2 4
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 13 5 18
        More than one race
    		 1 0 1
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Australia
    		 0 2 2
        Italy
    		 5 2 7
        Spain
    		 1 0 1
        United Kingdom
    		 6 2 8
        United States
    		 4 1 5

    End points

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    End points reporting groups
    Reporting group title
    Ramucirumab + Gemcitabine + Docetaxel
    Reporting group description
    		 Participants received intravenous infusions of ramucirumab 9 milligrams per kilogram (mg/kg), gemcitabine 900 milligrams per meter square (mg/m2) on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Gemcitabine + Docetaxel
    Reporting group description
    		 Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    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 randomization until the first investigator-determined objective progression as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 (RECIST v1.1) or death from any cause in the absence of progressive disease. Participants known to be alive and without disease progression will be censored at the time of the last adequate tumor assessment or date of randomization, whichever is later. Analysis Population Description: All randomized participants (including the censored participants). Number of participants censored in Ramucirumab + Gemcitabine + Docetaxel=4, Gemcitabine + Docetaxel=2.
    End point type
    Primary
    End point timeframe
    Baseline to Objective Progression or Death Due to Any Cause (Up To 6.4 Months)
    End point values
    		 Ramucirumab + Gemcitabine + Docetaxel Gemcitabine + Docetaxel
    Number of subjects analysed
    16
    7 [1]
    Units: Months
        median (confidence interval 80%)
    2.10 (2 to 6)
    2.03 (1.38 to 9999)
    Notes
    [1] - 9999=NA=There were not enough events to estimate the upper confidence limit.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    To conclude success for the intervention, the Bayesian analysis must yield a minimum of 99% posterior probability for PFS Hazard ratio less than 1 [i.e., Pr(HR < 1) > 99%]. The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.
    Comparison groups
    Ramucirumab + Gemcitabine + Docetaxel v Gemcitabine + Docetaxel
    Number of subjects included in analysis
    23
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.051
    Method
    		 Bayesian hierarchical model]
    Parameter type
    		 Posterior Mean Hazard Ratio
    Point estimate
    2.62
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 1.19
         upper limit
    		 4.46

    Secondary: Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)

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    End point title
    		 Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
    End point description
    ORR is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Analysis Population Description: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline through Measured Progressive Disease (Up To 6.4 Months)
    End point values
    		 Ramucirumab + Gemcitabine + Docetaxel Gemcitabine + Docetaxel
    Number of subjects analysed
    16
    7
    Units: Percentage of participants
        number (confidence interval 80%)
    6.3 (0.7 to 22.2)
    0 (0 to 28)
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR)
    End point description
    DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence. Analysis Population Description: All randomized participants who had CR or PR responses. For Gemcitabine + Docetaxel, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed.
    End point type
    Secondary
    End point timeframe
    Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 4.13 Months)
    End point values
    		 Ramucirumab + Gemcitabine + Docetaxel Gemcitabine + Docetaxel
    Number of subjects analysed
    1 [2]
    0 [3]
    Units: Months
        number (not applicable)
    9999
    Notes
    [2] - 9999=N/A=DoR couldn't be calculated as the participant did not achieve the event and was censored.
    [3] - Zero participants analysed as there were no participants with CR or PR responses to evaluate DoR.
    No statistical analyses for this end point

    Secondary: Complete Response (CR): Percentage of Participants Who Achieve CR

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    End point title
    		 Complete Response (CR): Percentage of Participants Who Achieve CR
    End point description
    CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. Analysis Population Description: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline Up to 6.94 months
    End point values
    		 Ramucirumab + Gemcitabine + Docetaxel Gemcitabine + Docetaxel
    Number of subjects analysed
    16
    7
    Units: Percentage of participants
        number (confidence interval 80%)
    0 (0 to 13.4)
    0 (0 to 28)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)

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    End point title
    		 Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax) [4]
    End point description
    Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose and was summarized using descriptive statistics. Analysis Population Description: All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    0.5 hours after the end of ramucirumab infusion on Day 1 of Cycle 1
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome is planned for Ramucirumab arm only.
    End point values
    		 Ramucirumab + Gemcitabine + Docetaxel
    Number of subjects analysed
    10
    Units: microgram per milliliter (µg/mL)
        geometric mean (geometric coefficient of variation)
    231 ± 43
    No statistical analyses for this end point

    Secondary: PK: Minimum Serum Concentration of Ramucirumab (Cmin)

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    End point title
    		 PK: Minimum Serum Concentration of Ramucirumab (Cmin) [5]
    End point description
    Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics. Analysis Population Description: All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome is planned for Ramucirumab arm only.
    End point values
    		 Ramucirumab + Gemcitabine + Docetaxel
    Number of subjects analysed
    10 [6]
    Units: microgram per milliliter (µg/mL)
    geometric mean (geometric coefficient of variation)
        Day 8 of Cycle 1, N=9
    73.3 ± 39
        Day 1 of Cycle 2, N=10
    55.4 ± 24
        Day 1 of Cycle 5, N=2
    9999 ± 9999
    Notes
    [6] - 9999=N/A due to insufficient participants. Individual values reported: 32.4 µg/mL, 41.3 µg/mL.
    No statistical analyses for this end point

    Secondary: Number of Participants with Treatment-Emergent Anti-Drug Antibodies (TE-ADA)

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    End point title
    		 Number of Participants with Treatment-Emergent Anti-Drug Antibodies (TE-ADA)
    End point description
    A TE-ADA evaluable participant is considered to be TE-ADA positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement (treatment-boosted). If baseline result is ADA Not Present, then the participant is TE ADA positive if there is at least one post baseline result of ADA Present with titer >= 20 (treatment-induced). Analysis Population Description: All randomized participants who received at least one dose of study drug and had at least one non-missing baseline, post baseline ADA value.
    End point type
    Secondary
    End point timeframe
    Baseline Up to 6.94 months
    End point values
    		 Ramucirumab + Gemcitabine + Docetaxel Gemcitabine + Docetaxel
    Number of subjects analysed
    7
    1
    Units: participants
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up to 6.94 months
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Gemcitabine + Docetaxel
    Reporting group description
    		 Participants received intravenous infusions of gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.

    Reporting group title
    Ramucirumab + Gemcitabine + Docetaxel
    Reporting group description
    		 Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met

    Serious adverse events
    		 Gemcitabine + Docetaxel Ramucirumab + Gemcitabine + Docetaxel
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    8 / 16 (50.00%)
         number of deaths (all causes)
    4
    8
         number of deaths resulting from adverse events
    Investigations
    platelet count decreased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    embolism
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    febrile neutropenia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    pyrexia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    mallory-weiss syndrome
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    laryngeal haemorrhage
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    pneumonia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Gemcitabine + Docetaxel Ramucirumab + Gemcitabine + Docetaxel
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 6 (100.00%)
    15 / 16 (93.75%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    hypotension
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    lymphoedema
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    superficial vein thrombosis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    4
    fatigue
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    4 / 6 (66.67%)
    4 / 16 (25.00%)
         occurrences all number
    5
    6
    mucosal inflammation
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    non-cardiac chest pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    3
    oedema peripheral
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    3 / 16 (18.75%)
         occurrences all number
    1
    3
    pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    pyrexia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    5 / 16 (31.25%)
         occurrences all number
    0
    9
    Respiratory, thoracic and mediastinal disorders
    epistaxis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    6 / 16 (37.50%)
         occurrences all number
    1
    8
    emphysema
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    dyspnoea
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    cough
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    nasal congestion
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    nasal dryness
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    productive cough
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    pleuritic pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    pneumothorax
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    rhinalgia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Investigations
    activated partial thromboplastin time prolonged
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    alanine aminotransferase
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    blood glucose increased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    6 / 16 (37.50%)
         occurrences all number
    1
    10
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 6 (33.33%)
    7 / 16 (43.75%)
         occurrences all number
    3
    14
    lymphocyte count decreased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    neutrophil count decreased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    5 / 16 (31.25%)
         occurrences all number
    0
    10
    platelet count decreased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    6 / 16 (37.50%)
         occurrences all number
    4
    10
    weight increased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    white blood cell count decreased
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 16 (25.00%)
         occurrences all number
    7
    8
    Injury, poisoning and procedural complications
    wound dehiscence
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Cardiac disorders
    sinus tachycardia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 6 (33.33%)
    4 / 16 (25.00%)
         occurrences all number
    2
    4
    dizziness
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    presyncope
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    neuropathy peripheral
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    sciatic nerve neuropathy
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    syncope
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    taste disorder
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 6 (33.33%)
    7 / 16 (43.75%)
         occurrences all number
    4
    8
    leukopenia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    neutropenia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    5 / 16 (31.25%)
         occurrences all number
    4
    11
    thrombocytopenia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    Ear and labyrinth disorders
    ear pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Eye disorders
    blepharitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    periorbital oedema
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    retinal haemorrhage
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    4 / 16 (25.00%)
         occurrences all number
    1
    4
    aphthous ulcer
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    gingival pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    enterocolitis haemorrhagic
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    dyspepsia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    diarrhoea
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 6 (33.33%)
    3 / 16 (18.75%)
         occurrences all number
    2
    4
    constipation
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    6 / 16 (37.50%)
         occurrences all number
    1
    8
    nausea
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    5 / 16 (31.25%)
         occurrences all number
    1
    11
    odynophagia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    vomiting
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    7 / 16 (43.75%)
         occurrences all number
    3
    9
    stomatitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    2 / 6 (33.33%)
    5 / 16 (31.25%)
         occurrences all number
    3
    6
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    erythema
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    dry skin
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    dermatitis acneiform
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    nail disorder
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    onychomadesis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    pain of skin
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    palmar-plantar erythrodysaesthesia syndrome
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 16 (25.00%)
         occurrences all number
    0
    9
    pruritus
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    rash
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    rash maculo-papular
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    skin discolouration
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    skin disorder
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    skin ulcer
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    haematuria
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    proteinuria
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    4 / 16 (25.00%)
         occurrences all number
    0
    4
    urinary retention
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    bone pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    back pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    4
    arthralgia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    muscle spasms
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    muscular weakness
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    myalgia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    neck pain
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    pain in extremity
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    6 / 16 (37.50%)
         occurrences all number
    0
    7
    Infections and infestations
    cellulitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    covid-19
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    asymptomatic covid-19
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    folliculitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    3
    eye infection
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    conjunctivitis
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    paronychia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    pneumonia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    urinary tract infection
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    skin infection
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    hyperglycaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    fluid retention
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    decreased appetite
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    hyperkalaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    hyperphosphataemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    hypoalbuminaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    hypocalcaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    hypoglycaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    1 / 6 (16.67%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    hypokalaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    hypomagnesaemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    hyponatraemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    hypophosphataemia
    alternative dictionary used: MedDRA 25.1
         subjects affected / exposed
    0 / 6 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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.
    The limitation to this study was the highly varied estimates of the PFS HR and the probability of PFS HR < 1 due to influence from the matched historical controls whose PFS substantially outperformed PFS from the prospectively randomized control.
    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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