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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00849667
Registration number
NCT00849667
Ethics application status
Date submitted
13/02/2009
Date registered
24/02/2009
Date last updated
30/12/2022
Titles & IDs
Public title
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
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Scientific title
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
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Secondary ID [1]
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2008-005872-29
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Secondary ID [2]
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MORAb003-004
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Inflammatory and Immune System
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0
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Allergies
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Farletuzumab
Treatment: Drugs - Carboplatin
Treatment: Drugs - Taxane
Treatment: Drugs - Farletuzumab-matched placebo
Active Comparator: Farletuzumab (1.25 mg/kg) - Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel [175 milligram per meter square {mg/m^2}] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain area under curve [AUC] 5-6 milligram per milliliter per minute [mg/mL/minute]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression.
Active Comparator: Farletuzumab (2.5 mg/kg) - Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression.
Placebo Comparator: Placebo - Participants will receive farletuzumab-matched placebo (0.9 percent [%] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel [175 mg/m^2] or docetaxel [75 mg/m^2]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.
Treatment: Drugs: Farletuzumab
Farletuzumab IV infusion.
Treatment: Drugs: Carboplatin
Carboplatin IV infusion.
Treatment: Drugs: Taxane
Taxane (Paclitaxel or Docetaxel) IV infusion.
Treatment: Drugs: Farletuzumab-matched placebo
Farletuzumab-matched placebo IV infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression based on the independent radiologic assessment (modified response evaluation criteria in solid tumors [RECIST]), or date of death, whatever the cause. As per RECIST, disease progression was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions. If progression or death was not observed for a participant, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
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Timepoint [1]
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From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS was defined as the time (in months) from the date of randomization to the date of death, due to any cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
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Timepoint [1]
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From the date of randomization until date of death from any cause, or study termination by sponsor, whichever came first (up to 48 months)
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Secondary outcome [2]
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Cancer Antigen-125 (CA-125) Progression-Free Survival
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Assessment method [2]
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CA-125 PFS was defined as the time (in months) from the date of randomization until the date of the first observation of progression based on the Rustin criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, the CA-125 PFS time was censored at the date of the last CA-125 assessment without evidence of progression before the date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Based on Rustin criteria, progressive disease (PD) was a rise in CA125 since beginning of consolidation or previously normal CA125 that rises to greater than or equal to (>=) 2 multiple (*) ULN with either event documented on two occasions or CA-125 >=2*nadir value with either event documented on two occasions.
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Timepoint [2]
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From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
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Secondary outcome [3]
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Progression-Free Survival Based on Gynecologic Cancer InterGroup (GCIG) Criteria
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Assessment method [3]
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PFS using GCIG criteria was defined as time (in months) from date of randomization until date of first observation of progression based on GCIG criteria, or date of death, whatever the cause. If progression or death was not observed for a participant, GCIG PFS time was censored at later date of last tumor assessment or CA-125 assessment without evidence of progression before date of initiation of further antitumor treatment or the "primary analysis cut off" date, whichever was earlier. Disease progression per GCIG: Participants with elevated CA-125 pretreatment and normalisation of CA-125 must show evidence of CA-125 >=two times ULN on two occasions at least one week apart or participants with elevated CA-125 pretreatment, which never normalises must show evidence of CA-125 >=two times nadir value on two occasions at least one week apart or participants with CA-125 in normal range pretreatment must show evidence of CA-125 >=two times ULN on two occasions at least one week apart.
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Timepoint [3]
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From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 44 months)
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Secondary outcome [4]
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Percentage of Participants With Length of Second Remission Greater Than First Remission
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Assessment method [4]
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Length of first remission was defined as a.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy until date of first relapse (that is, first observation of progression). It was assumed that the date of first relapse was the earlier of progression by CA-125 or progression by radiologic assessment, as judged by the investigator using GCIG criteria. b.) the period of time (in months) from the date of completion of previous platinum-based chemotherapy (used prior to study entry) until date of randomization. The length of the second remission was defined as the period of time (in months) from the date of completion of platinum-based chemotherapy until the first observation of progression based on GCIG criteria. Based on GCIG criteria, disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the baseline sum of diameters of target lesions.
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Timepoint [4]
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From the date of last dose of platinum-based chemotherapy to date of relapse and date of last dose of platinum-based chemotherapy to first observation of progression (up to 48 months)
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Secondary outcome [5]
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Percentage of Participants With Objective Response
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Assessment method [5]
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Objective response was defined as either a confirmed complete response (CR) or confirmed partial response (PR) as assessed by investigator based on response evaluation criteria in solid tumors version 1.1 (RECIST version 1.1). CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
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Timepoint [5]
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From the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first (up to 48 months)
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Secondary outcome [6]
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Duration of Tumor Response
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Assessment method [6]
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Duration of response was defined as the time (in months) from first documentation of objective response (confirmed CR or PR) to the first documentation of objective tumor progression or death due to any cause. Duration of response was derived only for those participants with objective evidence of confirmed CR or PR.
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Timepoint [6]
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From the first date of confirmed objective response (CR or PR) to first date of progression or death due to any cause (up to 48 months)
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Secondary outcome [7]
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Time to Tumor Response (TTR)
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Assessment method [7]
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Time to tumor response was defined as the time (in months) from the date of randomization to first documentation of objective tumor response. Time to tumor response was derived for those participants with objective evidence of CR or PR.
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Timepoint [7]
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From the date of randomization to first documentation of objective response (up to 48 months)
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Secondary outcome [8]
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Percentage of Participants With Serologic Response (SR)
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Assessment method [8]
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SR was defined as either normalization, 75% response, or 50% response using the Rustin criteria. Percentage of participants with 50% SR, 75% SR and SR leading to normalization were reported. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of four CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level). A 75% response was established if there had a serial decrease in serum CA-125 levels of 75% over three samples. In both the 50% and 75% response definitions, the final sample was analyzed at least 28 days after the previous sample.
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Timepoint [8]
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Up to 48 months
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Secondary outcome [9]
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Duration of 50% Serologic Response
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Assessment method [9]
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Duration of SR was defined as the time (in months) from first documentation of response to the first documentation of 50% serologic progression or death due to any cause. For responding participants who did not have serologic progression or did not die and who 1) were either still on study at the time of an analysis, 2) were given antitumor treatment other than study treatment, or 3) were withdrawn from study follow-up before documentation of serologic progression, the duration of SR was censored at the last date the participant was known to be without serologic progression. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).
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Timepoint [9]
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From the first date of documentation of response to first documentation of serologic progression or death due to any cause (up to 48 months)
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Secondary outcome [10]
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Time to 50% Serologic Response (TSR)
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Assessment method [10]
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TSR was defined as the time (in months) from the date of randomization to first documentation of 50% SR. A 50% response according to CA-125 was defined as a 50% decrease in serum CA-125 levels, as determined through a series of three CA-125 samples (one baseline sample with an elevated level, the sample that showed a 50% decrease, and a confirmatory sample at the decreased level).
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Timepoint [10]
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From the date of randomization to first documentation of 50% SR (up to 48 months)
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Secondary outcome [11]
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Percentage of Participants With Clinical Benefit
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Assessment method [11]
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Clinical benefit was defined as a confirmed CR or a confirmed PR, or stable disease (SD) using RECIST 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference smallest sum of longest dimensions since treatment started associated to non-progressive disease response for non target lesions.
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Timepoint [11]
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Up to 48 months
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Secondary outcome [12]
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Cmax: Maximum Observed Plasma Concentration of Total Carboplatin and Total Paclitaxel
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Assessment method [12]
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Timepoint [12]
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Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
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Secondary outcome [13]
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Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) of Total Carboplatin and Total Paclitaxel
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Assessment method [13]
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Timepoint [13]
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Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
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Secondary outcome [14]
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AUC (0-inf): Area Under the Concentration-time Curve From Zero (Pre-dose) Extrapolated to Infinite Time of Total Carboplatin and Total Paclitaxel
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Assessment method [14]
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Timepoint [14]
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Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
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Secondary outcome [15]
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T1/2: Terminal Half-life of Total Carboplatin and Total Paclitaxel
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Assessment method [15]
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Timepoint [15]
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Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
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Secondary outcome [16]
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CL: Clearance of Total Carboplatin and Total Paclitaxel
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Assessment method [16]
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Timepoint [16]
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Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
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Secondary outcome [17]
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Vd: Volume of Distribution of Total Carboplatin and Total Paclitaxel
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Assessment method [17]
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Timepoint [17]
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Cycle 2 Week 1 Day 1: 0-45 hours post-dose (cycle length=21 days)
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Secondary outcome [18]
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Mean Functional Assessment of Cancer Therapy-Ovarian Treatment Outcome Index (FACT-O TOI) Scores
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Assessment method [18]
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Participant-reported Quality of Life (QoL) was measured using the Functional Assessment of Cancer Therapy-Ovarian (FACT-O), version 4 and reported in the Treatment Outcome Index (TOI) format. TOI is a 26-item subset of the FACT-O questionnaire composed of the raw sum of the physical well-being subscale (7 items), the functional well-being subscale (7 items), and the ovarian cancer subscale (12 items). Each item was scored on a scale of 0 (not at all) to 4 (very much). Some items were reversed scored. Scores from each subsection were summed into one composite score, termed the FACT-O TOI score which ranged from 0 to 104 and a higher score reflected better QoL. As per planned analysis, farletuzumab treatment groups 1.25 mg/kg and 2.5 mg/kg were pooled for the QoL assessment.
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Timepoint [18]
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Cycle 3, Cycle 6, Cycle 12 (each cycle length=21 days)
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Eligibility
Key inclusion criteria
- A histologically or cytologically confirmed diagnosis of non-mucinous epithelial
ovarian cancer including primary peritoneal or fallopian tube malignancies
- Must have measurable disease by CT or MRI scan
- Must have relapsed radiologically with a randomization date within =6 and < 24 months
of completion of first-line platinum chemotherapy
- Have been treated with debulking surgery and first-line platinum and taxane based
chemotherapy.
- Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been
at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or
cancer vaccine therapy is allowed.
- Must be a candidate for carboplatin and taxane therapy
- Neurologic function: neuropathy (sensory and motor) =CTCAE Grade 1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Subjects who never responded to first-line platinum-based therapy or whose first
relapse occurs <6 months or >24 months from the last platinum therapy
- Subjects who have received other therapy to treat their ovarian cancer since relapse
- Known central nervous system (CNS) tumor involvement
- Evidence of other active invasive malignancy requiring treatment in the past 5 years
- Known allergic reaction to a prior monoclonal antibody therapy or have any documented
HAHA
- Previous treatment with MORAb-003 (farletuzumab)
- Clinical contraindications to use of a taxane
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/04/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/04/2013
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Sample size
Target
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Accrual to date
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Final
1100
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Tweed Hospital - Tweed Heads
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Westmead Hospital - Westmead
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The Royal Brisbane and Women's Hospital - Herston
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Mater Adult Hospital - South Brisbane
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Recruitment hospital [5]
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North Adelaide Oncology Clinical Trials - North Adelaide
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Recruitment hospital [6]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment postcode(s) [1]
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2485 - Tweed Heads
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4029 - Herston
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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5006 - North Adelaide
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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Santa Fe
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Austria
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Wien
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Country [51]
0
0
Belgium
Query!
State/province [51]
0
0
Liège
Query!
Country [52]
0
0
Belgium
Query!
State/province [52]
0
0
Wilrijk
Query!
Country [53]
0
0
Brazil
Query!
State/province [53]
0
0
Barretos
Query!
Country [54]
0
0
Brazil
Query!
State/province [54]
0
0
Caxias do Sul
Query!
Country [55]
0
0
Brazil
Query!
State/province [55]
0
0
Curitiba
Query!
Country [56]
0
0
Brazil
Query!
State/province [56]
0
0
Fortaleza
Query!
Country [57]
0
0
Brazil
Query!
State/province [57]
0
0
Goiania
Query!
Country [58]
0
0
Brazil
Query!
State/province [58]
0
0
Ijuí
Query!
Country [59]
0
0
Brazil
Query!
State/province [59]
0
0
Itajai
Query!
Country [60]
0
0
Brazil
Query!
State/province [60]
0
0
Jaú
Query!
Country [61]
0
0
Brazil
Query!
State/province [61]
0
0
Natal
Query!
Country [62]
0
0
Brazil
Query!
State/province [62]
0
0
Porto Alegre
Query!
Country [63]
0
0
Brazil
Query!
State/province [63]
0
0
Ribeirão Preto
Query!
Country [64]
0
0
Brazil
Query!
State/province [64]
0
0
Rio De Janeiro - RJ
Query!
Country [65]
0
0
Brazil
Query!
State/province [65]
0
0
Rio de Janeiro
Query!
Country [66]
0
0
Brazil
Query!
State/province [66]
0
0
Salvador
Query!
Country [67]
0
0
Brazil
Query!
State/province [67]
0
0
Santo André
Query!
Country [68]
0
0
Brazil
Query!
State/province [68]
0
0
São Paulo
Query!
Country [69]
0
0
Canada
Query!
State/province [69]
0
0
Alberta
Query!
Country [70]
0
0
Canada
Query!
State/province [70]
0
0
British Columbia
Query!
Country [71]
0
0
Canada
Query!
State/province [71]
0
0
New Brunswick
Query!
Country [72]
0
0
Canada
Query!
State/province [72]
0
0
Ontario
Query!
Country [73]
0
0
Chile
Query!
State/province [73]
0
0
Santiago
Query!
Country [74]
0
0
Chile
Query!
State/province [74]
0
0
Temuco
Query!
Country [75]
0
0
Chile
Query!
State/province [75]
0
0
Viña del Mar
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Angers Cedex 9
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Le Coudray
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Marseille
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Paris Cedex 10
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Reims
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Berlin-Buch
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Berlin
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Chemnitz
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Düsseldorf
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Ebersberg
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Essen
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Frankfurt
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Freiburg
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Hamburg
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Heidelberg
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Karlsruhe
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Magdeburg
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Mainz
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
München
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Rostock
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Traunstein
Query!
Country [97]
0
0
Greece
Query!
State/province [97]
0
0
Crete
Query!
Country [98]
0
0
Greece
Query!
State/province [98]
0
0
Athens
Query!
Country [99]
0
0
Greece
Query!
State/province [99]
0
0
Patras
Query!
Country [100]
0
0
Greece
Query!
State/province [100]
0
0
Thessaloniki
Query!
Country [101]
0
0
Hong Kong
Query!
State/province [101]
0
0
Islands
Query!
Country [102]
0
0
Hong Kong
Query!
State/province [102]
0
0
Tuen Mun
Query!
Country [103]
0
0
Hungary
Query!
State/province [103]
0
0
Budapest
Query!
Country [104]
0
0
Hungary
Query!
State/province [104]
0
0
Gyor
Query!
Country [105]
0
0
Hungary
Query!
State/province [105]
0
0
Kecskemét
Query!
Country [106]
0
0
Hungary
Query!
State/province [106]
0
0
Miskolc
Query!
Country [107]
0
0
Hungary
Query!
State/province [107]
0
0
Szolnok
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Veszprém
Query!
Country [109]
0
0
India
Query!
State/province [109]
0
0
Gujarat
Query!
Country [110]
0
0
India
Query!
State/province [110]
0
0
Karnataka
Query!
Country [111]
0
0
India
Query!
State/province [111]
0
0
Madhya Pradesh
Query!
Country [112]
0
0
India
Query!
State/province [112]
0
0
Maharashtra
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Tamil Nadu
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
West Bengal
Query!
Country [115]
0
0
India
Query!
State/province [115]
0
0
Bangalore
Query!
Country [116]
0
0
India
Query!
State/province [116]
0
0
Cochin
Query!
Country [117]
0
0
India
Query!
State/province [117]
0
0
Hyderabaad
Query!
Country [118]
0
0
India
Query!
State/province [118]
0
0
Jaipur
Query!
Country [119]
0
0
India
Query!
State/province [119]
0
0
Kochi
Query!
Country [120]
0
0
India
Query!
State/province [120]
0
0
Mumbai
Query!
Country [121]
0
0
India
Query!
State/province [121]
0
0
Nashik
Query!
Country [122]
0
0
India
Query!
State/province [122]
0
0
Nasik
Query!
Country [123]
0
0
India
Query!
State/province [123]
0
0
New Delhi
Query!
Country [124]
0
0
India
Query!
State/province [124]
0
0
Trivandrum
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Haifa
Query!
Country [126]
0
0
Israel
Query!
State/province [126]
0
0
Holon
Query!
Country [127]
0
0
Israel
Query!
State/province [127]
0
0
Jerusalem
Query!
Country [128]
0
0
Israel
Query!
State/province [128]
0
0
Kfar Saba
Query!
Country [129]
0
0
Israel
Query!
State/province [129]
0
0
Petach Tikva
Query!
Country [130]
0
0
Israel
Query!
State/province [130]
0
0
Ramat-Gan
Query!
Country [131]
0
0
Israel
Query!
State/province [131]
0
0
Rehovot
Query!
Country [132]
0
0
Israel
Query!
State/province [132]
0
0
Zerifin
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Pordenone
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Alessandria
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Bologna
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Brescia
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Campobasso
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Catania
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Como
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Faenza
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Genova
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Lecce
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Legnago
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Meldola
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Milano
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Napoli
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Negrar
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Padova
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Perugia
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Ravenna
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Reggio Emilia
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Roma
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Udine
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Akashi
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Amagasaki
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Chiba
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Fukuoka
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Hidaka
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Hiroshima
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Kagoshima
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Kashiwa
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Kawasaki
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Koto-Ku
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Kumamoto
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Kure
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Kurume
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Matsuyama
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Minato-Ku
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Morioka
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Nagoya
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Nakano-Ku
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Niigata
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Okayama
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Osakasayama
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Osaka
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Sapporo
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Sendai
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Shinjuku-Ku
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Sunto-Gun
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Tsukuba
Query!
Country [181]
0
0
Japan
Query!
State/province [181]
0
0
Tsu
Query!
Country [182]
0
0
Japan
Query!
State/province [182]
0
0
Yamagata
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Yonago
Query!
Country [184]
0
0
Korea, Republic of
Query!
State/province [184]
0
0
Gyeonggi-do
Query!
Country [185]
0
0
Korea, Republic of
Query!
State/province [185]
0
0
In Cheon
Query!
Country [186]
0
0
Korea, Republic of
Query!
State/province [186]
0
0
Seoul
Query!
Country [187]
0
0
Mexico
Query!
State/province [187]
0
0
Colima
Query!
Country [188]
0
0
Mexico
Query!
State/province [188]
0
0
Morelia
Query!
Country [189]
0
0
Mexico
Query!
State/province [189]
0
0
Veracruz
Query!
Country [190]
0
0
Netherlands
Query!
State/province [190]
0
0
Amsterdam
Query!
Country [191]
0
0
Netherlands
Query!
State/province [191]
0
0
Dordrecht
Query!
Country [192]
0
0
Netherlands
Query!
State/province [192]
0
0
Maastricht
Query!
Country [193]
0
0
Netherlands
Query!
State/province [193]
0
0
Sittard-Geleen
Query!
Country [194]
0
0
Philippines
Query!
State/province [194]
0
0
Cebu
Query!
Country [195]
0
0
Philippines
Query!
State/province [195]
0
0
Manila
Query!
Country [196]
0
0
Philippines
Query!
State/province [196]
0
0
Pasay City
Query!
Country [197]
0
0
Philippines
Query!
State/province [197]
0
0
Quezon City
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Bialystok
Query!
Country [199]
0
0
Poland
Query!
State/province [199]
0
0
Gdansk
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Gliwice
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Lodz
Query!
Country [202]
0
0
Poland
Query!
State/province [202]
0
0
Lublin
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Olsztyn
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Poznan
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Rybnik
Query!
Country [206]
0
0
Poland
Query!
State/province [206]
0
0
Szczecin
Query!
Country [207]
0
0
Poland
Query!
State/province [207]
0
0
Warszawa
Query!
Country [208]
0
0
Portugal
Query!
State/province [208]
0
0
Coimbra
Query!
Country [209]
0
0
Portugal
Query!
State/province [209]
0
0
Lisboa
Query!
Country [210]
0
0
Portugal
Query!
State/province [210]
0
0
Porto
Query!
Country [211]
0
0
Russian Federation
Query!
State/province [211]
0
0
Kursk
Query!
Country [212]
0
0
Russian Federation
Query!
State/province [212]
0
0
Moscow
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Obninsk
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Ryazan
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
St. Petersburg
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Ufa
Query!
Country [217]
0
0
Singapore
Query!
State/province [217]
0
0
Singapore
Query!
Country [218]
0
0
Spain
Query!
State/province [218]
0
0
Andalucía
Query!
Country [219]
0
0
Spain
Query!
State/province [219]
0
0
Baleares
Query!
Country [220]
0
0
Spain
Query!
State/province [220]
0
0
Cataluna
Query!
Country [221]
0
0
Spain
Query!
State/province [221]
0
0
Cataluña
Query!
Country [222]
0
0
Spain
Query!
State/province [222]
0
0
Comunidad Valenciana
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Madrid, Communidad De
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Madrid
Query!
Country [225]
0
0
Switzerland
Query!
State/province [225]
0
0
Zürich
Query!
Country [226]
0
0
Taiwan
Query!
State/province [226]
0
0
Tainan
Query!
Country [227]
0
0
Taiwan
Query!
State/province [227]
0
0
Taipei
Query!
Country [228]
0
0
Taiwan
Query!
State/province [228]
0
0
Taoyuan
Query!
Country [229]
0
0
Ukraine
Query!
State/province [229]
0
0
Cherkasy
Query!
Country [230]
0
0
Ukraine
Query!
State/province [230]
0
0
Chernivtsi
Query!
Country [231]
0
0
Ukraine
Query!
State/province [231]
0
0
Kyiv
Query!
Country [232]
0
0
Ukraine
Query!
State/province [232]
0
0
Lutsk
Query!
Country [233]
0
0
United Kingdom
Query!
State/province [233]
0
0
Belfast
Query!
Country [234]
0
0
United Kingdom
Query!
State/province [234]
0
0
Cardiff
Query!
Country [235]
0
0
United Kingdom
Query!
State/province [235]
0
0
Coventry
Query!
Country [236]
0
0
United Kingdom
Query!
State/province [236]
0
0
Dundee
Query!
Country [237]
0
0
United Kingdom
Query!
State/province [237]
0
0
Glasgow
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Country [238]
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United Kingdom
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Leicester
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Country [239]
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United Kingdom
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State/province [239]
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London
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Country [240]
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United Kingdom
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Plymouth
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Country [241]
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United Kingdom
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State/province [241]
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Poole
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Country [242]
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United Kingdom
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State/province [242]
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Sheffield
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Country [243]
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United Kingdom
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State/province [243]
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Wirral
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Country [244]
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United Kingdom
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State/province [244]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Morphotek
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Eisai Europe Ltd. (United Kingdom)
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This research is being done to find out if Carboplatin and Taxane works better alone or when
given with an experimental drug called MORAb-003(farletuzumab) in subjects with first
platinum sensitive relapsed ovarian cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00849667
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00849667
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