drugset / Trial / NCT01332656

Study of Ombrabulin in Patients With Platinum-Sensitive Recurrent Ovarian Cancer Treated With Carboplatin/Paclitaxel

NCT01332656 ↗

Phase 2 Completed 154 enrolled Sanofi
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Objective: \- To demonstrate an improvement in Progression-Free Survival (PFS) for Ombrabulin versus placebo in patients with platinum-sensitive recurrent ovarian cancer (OC) treated with paclitaxel and carboplatin. Secondary Objectives: * To compare the overall survival (OS) between the 2 treatment arms * To compare the objective response rate (RR) between the 2 treatment arms

Timeline

Start
2011-05
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ombrabulin Other / unclassified — Intravenous
Background Carboplatin Small molecule — Intravenous
Background Paclitaxel Small molecule — Intravenous

Indications