MORAb-003-011 is a global, multicenter, double-blind, randomized placebo-controlled study to assess the safety and efficacy of farletuzumab in combination with standard chemotherapy in subjects with low cancer antigen 125 (CA125) platinum-sensitive ovarian cancer in first relapse.
Participants will be enrolled into 1 of 2 chemotherapy treatment arms at the investigator's discretion: carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), and then randomized in a 2:1 ratio to receive weekly farletuzumab 5 mg/kg or placebo (ie, Test Article). All participants will receive a loading dose for the first 2 weeks of 10 mg/kg Test Article (farletuzumab or placebo). Participants will be stratified at randomization by individual chemotherapy treatment regimen (targeted 1:1 ratio) and platinum-free interval following first-line therapy (6 to 12 months vs greater than 12 to 36 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
332
Farletuzumab will be administered intravenously (IV) weekly
Placebo will be administered intravenously (IV) weekly
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Phoenix, Arizona, United States
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Los Angeles, California, United States
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Orange, California, United States
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Roseville, California, United States
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Sacramento, California, United States
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Progression Free Survival (PFS)
PFS was defined as the time (in months) from the date of randomization of a participant to the date of first observation of progression or date of death, whatever the cause. PFS was assessed based on the investigators' assessments utilizing Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Disease progression (PD) was defined as at least a 20 percent (%) increase or 5 millimeter (mm) increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS was estimated and analyzed using Kaplan-Meier method.
Time frame: From the date of randomization to the date of first documentation of PD, or date of death, whichever occurs first up to approximately 5 years 5 months
Overall Survival (OS)
OS was defined as the time from the date of randomization until the date of death. Participants were censored at the date of last known to be alive. OS was analyzed using Kaplan-Meier method.
Time frame: From the date of randomization until the date of death (up to approximately 5 years 5 months)
Number of Participants With Best Overall Response (BOR)
BOR was defined as the best response of complete response (CR) or partial response (PR) or stable disease (SD) for greater than or equal to(\>=)6 months recorded from the start of the treatment until PD or death, whichever occurred first based on investigator assessment per RECIST v1.1. CR:disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than(\<)10 mm. PR:at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as at least 20% increase (including an absolute increase of at least 5mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time frame: From first dose of study drug (Baseline) up to approximately 5 years 5 months
Time to Tumor Response (TTR)
TTR was defined as the time (in months) from the date of randomization to the date of first observation of response (PR or CR) (whichever status was recorded first). TTR was assessed based on investigator assessment utilizing RECIST 1.1. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.
Time frame: From the date of randomization until date of first observation of response (CR or PR) up to approximately 5 years 5 months
Duration of Response (DOR)
DOR was defined as the time (in months) from the date of first observation of response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1, or date of death, whatever the cause. CR: disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30 % decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time frame: From date of the first observation of CR or PR until the date of first observation of progression or date of death up to approximately 5 years 5 months
Percentage of Participants Achieving Each Second Platinum-Free Interval Stratified by First Platinum-Free Interval
Percentage of participants achieving each second platinum-free interval (\<6 months, 6-12 months, greater than \[\>\] 12-36 months, and \>36 months) stratified by first platinum-free interval (6 to 12 months and \>12 to 36 months) was reported. First platinum-free interval was defined as the date of completion of previous platinum-based chemotherapy until the date of first relapse (that is, first observation of progression). The date of first relapse was the progression date. Second platinum-free interval was defined as the date of completion of platinum-based chemotherapy (last dosing date) during the study until the date of progression or death (or censoring, if applicable).
Time frame: From the date of randomization to the date of first relapse (or first observation of progression/death) up to approximately 5 year 5 months
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Aurora, Colorado, United States
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Miami, Florida, United States
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Miramar, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
...and 58 more locations