CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 214 enrolled
Drug / intervention
bevacizumab +3 moredrug
Likely dose
bevacizumab 15 mg/kgfrom 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/NCT00434252
NCT00434252Phase 2Completed

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Bevacizumab in Combination With Carboplatin and Paclitaxel Chemotherapy for the First-Line Treatment of Patients With Metastatic Melanoma

Genentech, Inc.·interventional·Posted Feb 13, 2007·Updated Jul 18, 2017

In Brief

A Phase 2 clinical trial evaluating bevacizumab, carboplatin, and 2 other interventions for Melanoma. Completed, enrolled 214 participants.

Detailed Summary

This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed to estimate the efficacy and characterize the safety of bevacizumab when combined with carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metastatic melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 13, 2007
Enrollment StartFeb 1, 2007
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.4 years ago

Interventions

bevacizumabdrug

15 mg/kg by intravenous (IV) infusion on the first day of each 3-week cycle (dose was based on patient's weight at screening and remained the same throughout study)

carboplatindrug

Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 3-week cycle, for a maximum of 10 cycles

paclitaxeldrug

175 mg/m\^2 by IV infusion on the first day of each 3-week cycle (dose was based on patient's weight and could be adjusted for weight change)

placebodrug

Administered by IV infusion on the first day of each 3-week cycle