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    Clinical Trial Results:
    An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects with Platinum-sensitive Epithelial Ovarian Cancer in First Relapse

    Summary
    EudraCT number
    		 2009-015825-36
    Trial protocol
    		 DE  
    Global end of trial date
    05 Mar 2013

    Results information
    Results version number
    		 v4(current)
    This version publication date
    09 Feb 2022
    First version publication date
    15 Aug 2015
    Other versions
    		 v1 , v2 , v3
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    MORAb-003-002A
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01018563
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Morphotek
    Sponsor organisation address
    210 Welsh Pool Road, Exton, United States, 19341
    Public contact
    Eisai Medical Information, Morphotek, 1 888 422 4743, esi_medinfo@eisai.com
    Scientific contact
    Eisai Medical Information, Morphotek, 1 888 422 4743, esi_medinfo@eisai.com
    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
    05 Mar 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Mar 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To provide farletuzumab (MORAb-003) to subjects who were enrolled in the protocol MORAb-003-002 and appear to be deriving benefit.
    Protection of trial subjects
    This study was conducted in accordance with standard operating procedures of the sponsor (or designee), which are designed to ensure adherence to GCP guidelines as required by the following:-Principles of the World Medical Association Declaration of Helsinki 2013; - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products,International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; - Title 21 of the United States Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and IRB regulations and applicable sections of US 21 CFR Part 312;- European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All SUSARs will be reported, as required, to the Competent Authorities of all involved EU member states.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jan 2010
    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
    Germany: 1
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    3
    EEA total number of subjects
    1
    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)
    2
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects participated and received single-agent farletuzumab maintenance therapy in MORAb-003-002 study, achieved normalization of cancer antigen 125 levels and/or tumor assessment of complete/partial response(or stable disease and an investigator's assessment of a clinical benefit) after receiving farletuzumab plus chemotherapy to enter study.

    Pre-assignment
    Screening details
    		 Study enrolled 3 subjects who participated in the MORAb-003-002 study (NCT00318370), achieved a normalization of CA 125 levels and/or complete response or partial response after MORAb-003 in combination with standard chemotherapy, and received single-agent MORAb-003 maintenance therapy.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Farletuzumab 62.5 mg/m^2
    Arm description
    		 Subjects received farletuzumab 62.5 milligram per meter square (mg/m^2), intravenous infusion once weekly at the same dose level which subjects received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Farletuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Farletuzumab was administered by intravenous infusion once weekly at the same dose subjects were receiving in the MORAb-003-002 parent study (ie, 62.5 or 100 mg/m^2).

    Arm title
    		 Farletuzumab 100 mg/m^2
    Arm description
    		 Subjects received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose subjects received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Farletuzumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Farletuzumab was administered by intravenous infusion once weekly at the same dose subjects were receiving in the MORAb-003-002 parent study (ie, 62.5 or 100 mg/m^2).

    Number of subjects in period 1
    		Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Started
    2
    1
    Completed
    0
    0
    Not completed
    2
    1
         Termination of the study by Sponsor
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 Subjects received farletuzumab 62.5 or 100 mg/m^2, intravenous infusion once weekly at the same dose level which subjects received in the MORAb-003-002 (NCT00318370) parent study for up to 37.7 months in this study.

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 3 3
    Age categorical
    Units: subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        median (full range (min-max))
    		 58.0 (38 to 74) -
    Gender, Male/Female
    Units: subjects
        Female
    		 3 3
        Male
    		 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 0 0
        Unknown or Not Reported
    		 1 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 1 1
        More than one race
    		 0 0
        Unknown or Not Reported
    		 2 2
    Subject analysis sets

    Subject analysis set title
    Farletuzumab- All Subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    As per the planned analysis, the intention to treat population analysis set included all 3 subjects who were enrolled and received at least 1 dose of farletuzumab in this extension-of-treatment study.

    Subject analysis sets values
    		 Farletuzumab- All Subjects
    Number of subjects
    3
    Age categorical
    Units: subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    2
        From 65-84 years
    1
        85 years and over
    0
    Age Continuous
    Units: years
        median (full range (min-max))
    58.0 (38 to 74)
    Gender, Male/Female
    Units: subjects
        Female
    3
        Male
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    2
        Not Hispanic or Latino
    0
        Unknown or Not Reported
    1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0
        Asian
    0
        Native Hawaiian or Other Pacific Islander
    0
        Black or African American
    0
        White
    1
        More than one race
    0
        Unknown or Not Reported
    2

    End points

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    End points reporting groups
    Reporting group title
    Farletuzumab 62.5 mg/m^2
    Reporting group description
    		 Subjects received farletuzumab 62.5 milligram per meter square (mg/m^2), intravenous infusion once weekly at the same dose level which subjects received in the MORAb-003-002 (NCT00318370) parent study for up to approximately 37.7 months in this study.

    Reporting group title
    Farletuzumab 100 mg/m^2
    Reporting group description
    		 Subjects received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose subjects received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.

    Subject analysis set title
    Farletuzumab- All Subjects
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    As per the planned analysis, the intention to treat population analysis set included all 3 subjects who were enrolled and received at least 1 dose of farletuzumab in this extension-of-treatment study.

    Primary: Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response

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    End point title
    		 Duration of Ovarian Tumor Marker (Cancer Antigen 125 [CA125]) Response [1]
    End point description
    The duration of CA125 response, was defined the time from the date of the initial CA125 response (i.e., prior to enrollment in the parent study, was the starting point for assessment) to the first documentation of progressive disease (PD) by either Gynecologic Cancer Inter Group (GCIG) criteria for CA125 level or by the date of death due to any cause, whichever occurred first. Disease progression per CA125 was defined as the first of 2 consecutive CA125 values greater than (>) twice the upper limit of normal (ULN) (i.e. 35 kilo unit per liter [kU/L]) on two occasions. C= data censored at earlier non-PD assessment if PD did not occur. Intent-to-treat population included all 3 subjects who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.
    End point type
    Primary
    End point timeframe
    From screening of parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics data were planned to be analysed for this endpoint.
    End point values
    		 Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Number of subjects analysed
    2
    1
    Units: months
    number (not applicable)
        Subject 1 (dose group: 62.5 mg/m^2)-C
    77.2
    0
        Subject 2 (dose group: 62.5 mg/m^2)-C
    73.3
    0
        Subject 3 (dose group: 100 mg/m^2)
    0
    18.0
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS) by GCIG

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    End point title
    		 Progression-Free Survival (PFS) by GCIG
    End point description
    PFS was defined as time from first dose of study medication during parent study MORAb-003-002 (NCT00318370) to disease progression (either by GCIG for CA125 criteria or standard RECIST v.1.0 criteria) or death due to any cause in this study. PD per CA125 was the first of 2 consecutive CA125 values >2*ULN (35 kU/L) on two occasions. Subjects with no disease progression were censored at either the date of last CA125 assessment or date of last objective tumor evaluation, whichever was later. PFS was also censored if a subject received a non-study anticancer therapy or procedure, occurring at the date of the last RECIST or CA125 assessment prior to the start of a non-study anticancer therapy or procedure (whichever was earlier). C= data censored at earlier non-PD assessment if PD did not occur. Intent-to-treat population included all 3 subjects enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.
    End point type
    Secondary
    End point timeframe
    From the first dose of study medication in the parent study (NCT00318370) until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)
    End point values
    		 Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Number of subjects analysed
    2
    1
    Units: months
    number (not applicable)
        Subject 1 (dose group: 62.5 mg/m^2)-C: GCIG
    77.8
    0
        Subject 2 (dose group: 62.5 mg/m^2)-C: GCIG
    75.8
    0
        Subject 3 (dose group: 100 mg/m^2): GCIG
    0
    25.1
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS was defined from the date of first dose of farletuzumab during the parent study MORAb-003-002 (NCT00318370) to date of death due to any cause. Subjects who were alive had their OS time censored at the date they were last known to be alive. C= data censored at date subject was last known to be alive. Intent-to-treat population included all 3 subjects who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)
    End point values
    		 Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Number of subjects analysed
    2
    1
    Units: months
    number (not applicable)
        Subject 1 (dose group: 62.5 mg/m^2)-C
    78.3
    0
        Subject 2 (dose group: 62.5 mg/m^2)-C
    76.7
    0
        Subject 3 (dose group: 100 mg/m^2)
    0
    59.5
    No statistical analyses for this end point

    Secondary: Duration of Second Remission

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    End point title
    		 Duration of Second Remission
    End point description
    The prolongation of second and subsequent responses to chemotherapy plus farletuzumab relative to initial remission was assessed. Length of first remission was determined in the parent study MORAb-003-002 (NCT00318370). The length of second remission (i.e., the first remission in this study) was calculated using the following formula: ‘(carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1/30.4’. The length of second remission was censored at the date of study discontinuation if the subject did not receive any carboplatin/taxane therapy during this study. C = censored data. Intent-to-treat population included all 3 subjects who were enrolled. Data reported includes combined data from the parent study MORAb-003-002 (NCT00318370) and the current study MORAb-003-002A.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) in the parent study (NCT00318370) until date of death from any cause in this study, or until the current study was terminated (up to a maximum of 78.2 months including the parent study, or 37.7 months in this study only)
    End point values
    		 Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Number of subjects analysed
    2
    1
    Units: months
    number (not applicable)
        Subject 1 (dose group: 62.5 mg/m^2)
    41.0
    0
        Subject 2 (dose group: 62.5 mg/m^2)-C
    74.2
    0
        Subject 3 (dose group: 100 mg/m^2)
    0
    29.5
    No statistical analyses for this end point

    Secondary: Duration of Third Remission

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    End point title
    		 Duration of Third Remission
    End point description
    The length of third remission (i.e., second remission in this study) was calculated using the following formula: ‘(subsequent carboplatin/taxane start date in this study - carboplatin/taxane start date in NCT00318370 +1)/30.4’. The length of third remission was censored at the date of study discontinuation if the subject did not receive subsequent chemotherapy (carboplatin/taxane) during this study. Censored data is reported for all subjects. Intent-to-treat population included all 3 subjects who were enrolled.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) of this study until date of death from any cause, or until the study was terminated (up to a maximum of 37.7 months)
    End point values
    		 Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Number of subjects analysed
    1
    1
    Units: months
        number (not applicable)
    37.3
    25.0
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria

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    End point title
    		 Number of Subjects With Best Overall Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) V.1.0 Criteria
    End point description
    Best overall response was the best response recorded from the start of treatment until disease progression/recurrence. Subjects were assigned to one of the following categories of change in disease status: complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). CR was defined as CR in both target and non-target lesions with no new lesions. PR was defined as CR in target lesions and incomplete response or SD in non-target lesions with no new lesions, or PR in target lesions and non-PD in non-target lesions with no new lesions. SD was defined as SD in target lesions and non-PD in non-target lesions with no new lesions. PD was defined as PD in target lesions, any non-target lesions with either absence or presence of new lesions, or any target lesions, PD in non-target lesions with either absence or presence of new lesions, or any target or non-target lesions with new lesions. Intent-to-treat population included all 3 subjects who were enrolled.
    End point type
    Other pre-specified
    End point timeframe
    From the start of the treatment until disease progression/recurrence (up to approximately 37.7 months)
    End point values
    		 Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Number of subjects analysed
    2
    1
    Units: subjects
        CR
    1
    1
        SD
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    For each subject, from the first dose till 30 days after the last dose or up to study completion (approximately 37.7 months)
    Adverse event reporting additional description
    Intention to treat population analysis set included all 3 subjects who were enrolled.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Farletuzumab 62.5 mg/m^2
    Reporting group description
    		 Subjects received farletuzumab 62.5 mg/m^2, intravenous infusion once weekly at the same dose subjects received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.

    Reporting group title
    Farletuzumab 100 mg/m^2
    Reporting group description
    		 Subjects received farletuzumab 100 mg/m^2, intravenous infusion once weekly at the same dose subjects received in the MORAb-003-002 (NCT00318370) parent study up to approximately 37.7 months in this study.

    Serious adverse events
    		 Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoma
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (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
    Disease progression
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Farletuzumab 62.5 mg/m^2 Farletuzumab 100 mg/m^2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    1 / 1 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    5
    Hypotension
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    2
    11
    Local swelling
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    2
    Nasal congestion
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Obstructive Airways Disorder
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    1
    Panic Attack
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    0
    Red blood cell count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    4
    Traumatic haematoma
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    93
    2
    Tremor
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    3
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    2
    Neutropenia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    2
    Leukopenia
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    2
    3
    Diarrhoea
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    2
    7
    Stomatitis
         subjects affected / exposed
    2 / 2 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    Abdominal distension
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    1
    Colitis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    3
    Vomiting
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus allergic
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Swelling face
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    2
    Myalgia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Myosclerosis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Synovial Cyst
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Muscle Spasms
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Scoliosis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    3
    Fungal skin infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Otitis media
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Pharyngeal abscess
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Tooth infection
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Tinea versicolour
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Decreased appetite
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    Hypophosphataemia
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 1 (100.00%)
         occurrences all number
    2
    2
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 May 2011
    Part A. - Based on results of population pharmacokinetic (PK) studies, farletuzumab dosage was changed to Q3W intervals, using 3 times the weekly dose previously given. Due to this change, visits were changed to every 3 weeks, and all references to cycles were deleted. With the increased dose level, there was no need to dilute farletuzumab with normal saline. Instructions for preparation and administration of farletuzumab were updated accordingly - Farletuzumab was added to the product name to reflect the United States Adopted Names designation for MORAb-003 - Collection of serum samples for farletuzumab concentration was changed to every other visit (every 6 weeks) pre- and postinfusion in order to obtain additional information on serum levels maintained in this population. In addition, pre- and postinfusion serum samples were to be collected during the final 2 weekly visits prior to switching to the Q3W schedule - Collection of Human Anti-Human Antibody (HAHA) Results samples was changed to pre-infusion every other visit (every 6 weeks) - Due to the long-term follow-up in this population, the interval between Response Evaluation Criteria in Solid Tumors (RECIST) v.1.0 (Therasse et al., 2000) evaluations was increased to every 6 visits (every 18 weeks) as long as subjects remained clinically stable and the CA125 remained within normal limits. For any subjects receiving chemotherapy, the RECIST evaluations were changed to every 9 weeks (every 3 visits). Also, all RECIST evaluations were to be based on local radiology readings. All references to a central reader were deleted
    12 May 2011
    Part B. - A secondary objective was added to assess farletuzumab levels during Q3W dosing compared to drug levels during weekly dosing - The expected number of subjects was revised from 4 to 3. One of the expected subjects experienced a relapse and discontinued from the main study prior to initiation of the extension - Antibody-dependent cell cytotoxicity testing was removed from the protocol due to sample stability issues - Criteria for removal and replacement of study subjects were updated to include: An AE deemed to be intolerable, including a farletuzumab-related allergic reaction; A subject being lost to follow-up; A subject experiencing progressive disease by RECIST or CA125 criteria that is determined to be platinum-resistant/-refractory; A subject’s death

    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.
    Study was terminated by sponsor due to futile results in the NCT00849667 (MORAb003-004) study.
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