CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 265 enrolled
Drug / intervention
Tivozanib +2 moredrug
Likely dose
mFOLFOX6 85 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/NCT01478594
NCT01478594Phase 2Completed
CompareCT.gov

A Phase 2, Open Label, Multicenter, Randomized Trial Comparing Tivozanib in Combination With mFOLFOX6 to Bevacizumab in Combination With mFOLFOX6, In Stage IV Metastatic Colorectal Cancer (mCRC) Subjects

AVEO Pharmaceuticals, Inc.·interventional·Posted Nov 23, 2011·Updated Jul 8, 2015

In Brief

A Phase 2 clinical trial evaluating Tivozanib, Bevacizumab, and 1 other intervention for Colorectal Cancer. Completed, enrolled 265 participants across 73 sites in 12 countries.

Detailed Summary

The objective of this study is to compare the progression free survival (PFS), overall survival (OS), objective response rate (ORR), time to treatment failure (TTF), duration of response (DoR), quality of life, safety and tolerability of tivozanib in combination with mFOLFOX6 and bevacizumab in combination with mFOLFOX6.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesAustralia, Austria, Belgium, Canada, Czechia, Finland, Hungary, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 23, 2011
Enrollment StartDec 1, 2011
Primary CompletionSep 1, 2013
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.6 years ago

Interventions

Tivozanibdrug

Capsules for oral administration

Bevacizumabdrug

Solution for intravenous infusion

mFOLFOX6drug

mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, leucovorin calcium 400 mg/m\^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, fluorouracil 400 mg/m\^2 administered as an intravenous bolus over 5 to 15 minutes on Days 1 and 15, then 2400 mg/m\^2 continuous intravenous infusion over 46 hours on Days 1 to 3 and 15 to 17.