Clinical Research Details
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
Purpose:
The purpose of this study is to assess the effect of two dose levels of MORAb-003 or placebo in combination with carboplatin and taxane on progression-free survival (PFS) as determined by RECIST, in subjects with platinum-sensitive ovarian cancer in first relapse.
Study Number:
202218102109
Number of Patients:
900
Elgibility:
Participants must be women with a histologically or cytologically confirmed diagnosis of non-mucinous EOC (including primary peritoneal and fallopian tube malignancies). Participants must have been treated with surgery and first-line platinum and taxane-based chemotherapy and have first relapse after a remission within six - 24 months from these treatments. Participants must be candidates for repeat carboplatin/taxane therapy.
Treatment:
Participants will be assigned randomly into one of three treatment groups.
All groups will receive carboplatin and a taxane (paclitaxel or docetaxel). The taxane will be chosen by the participant’s physician.
Group 1 will receive an experimental drug (MORAb-003) at a lower dose.
Group 2 will receive an experimental drug (MORAb-003) at a higher dose.
Group 3 will receive a placebo, which looks the same as MORAb-003, but has no active study drug ingredients in it.
Principal Investigator:
Enrollment Phone:
(708) 327-3222