Trials / Completed
CompletedNCT00707889
Phase 2 Study of ABT-869 in Combination With mFOLFOX6 Versus Bevacizumab in Combination With mFOLFOX6 to Treat Advanced Colorectal Cancer
An Open-Label, Randomized Phase 2 Study of ABT-869 in Combination With mFOLFOX6 (Oxaliplatin, 5-Fluorouracil, and Folinic Acid) Versus Bevacizumab in Combination With mFOLFOX6 as Second-line Treatment of Subjects With Advanced Colorectal Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 159 (actual)
- Sponsor
- AbbVie (prior sponsor, Abbott) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To determine the effect of ABT-869 plus mFOLFOX6 compared to bevacizumab plus mFOLFOX6 on disease progression in advanced colorectal cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-869 | 12.5 mg QD, tablets taken orally days 1-14 of every 14-day cycle |
| DRUG | bevacizumab | 10 mg/kg QD, IV on Day 1 of each 14-day cycle |
| DRUG | oxaliplatin | 85 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle |
| DRUG | folinic acid | 400 mg/m2 IV, 120 minutes on Day 1 of each 14-day cycle |
| DRUG | fluorouracil | 400 mg/m2 IV bolus on Day 1 of each 14-day cycle; followed by 2400 mg/m2 IV infusion 46-48 hours |
| DRUG | ABT-869 | 7.5 mg QD tablets taken orally days 1-14 of every 14-day cycle |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2008-07-01
- Last updated
- 2013-05-15
Locations
46 sites across 14 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, Greece, New Zealand, Poland, Portugal, Romania, Russia, South Korea, Spain
Source: ClinicalTrials.gov record NCT00707889. Inclusion in this directory is not an endorsement.