Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT01367275
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Colorectal Adenocarcinoma
- Colorectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Brivanib — DRUG800 mg (4 x 200 mg tablets) self-administered orally at approximate same time each day on a continuous daily schedule Days 1-14 of 14 day cycle.
- Irinotecan — DRUG180 mg/m\^2 by vein on Day 1 of a 14 day cycle.
Study Details
The goal of this clinical research study is to learn if adding brivanib to irinotecan can help control the disease in patients with colorectal cancer that has spread. The safety of this drug combination will also be studied.
Key Dates
- Start date
- Aug 31, 2011
- Status verified
- Sep 2020
- Primary completion
- Nov 30, 2013
- Completion
- Nov 30, 2013
Study Design
- Enrollment
- 8 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Brivanib + IrinotecanBrivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1.
Primary Outcome Measure
Number of Participants With Median Progression-Free Survival (PFS) [ Time Frame: Enrollment (baseline) to disease progression or death, followed each 14 day treatment then every 2 months,up to 100 week ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | - |
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