Trials / Completed
CompletedNCT00921661
Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer
A Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Irinotecan/5-fluorouracil/Isovorin (FOLFIRI) Administered Every 2 Weeks in Patients With Metastatic Colorectal Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer. Secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AVE0005 (aflibercept) | IV infusion |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2009-06-16
- Last updated
- 2012-11-09
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00921661. Inclusion in this directory is not an endorsement.