A Randomized, Double-Blind, Placebo Controlled, Phase 2 Trial of Paclitaxel in Combination With AMG 386 in Subjects With Advanced Recurrent Epithelial Ovarian or Primary Peritoneal Cancer
Abstract
This study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome Measure:
• Progression free survival (PFS)
Secondary Outcome Measures:
* Object Response Rate (ORR), duration of response (DOR). CA-125 response rate
* Safety and Tolerability
* Change and duration of change on blood levels of CA-125
Conditions: Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer.
Primary outcome: Progression Free Survival.
Enrollment: 161 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 161 participants or records.
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