CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 484 enrolled
Drug / intervention
Carboplatin +3 moredrug
Likely dose
Bevacizumab 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00434642
NCT00434642Phase 3Completed
CompareCT.gov

A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma

Genentech, Inc.·interventional·Posted Feb 13, 2007·Updated Aug 9, 2017

In Brief

A Phase 3 clinical trial evaluating Carboplatin, Gemcitabine, and 2 other interventions for Ovarian Cancer. Completed, enrolled 484 participants.

Detailed Summary

This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2007
Enrollment StartApr 1, 2007
Primary CompletionSep 1, 2010
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 19.4 years ago

Interventions

Carboplatindrug

Carboplatin was provided as commercially available drug.

Gemcitabinedrug

Gemcitabine was provided as commercially available drug.

Bevacizumabdrug

Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL \[25 mg/mL\]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Placebodrug

Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.