Phase III Randomized Study of 5-FU, CoFactor, and Avastin vs. 5-FU, LV and Avastin for First-Line Colorectal Cancer.
Part of paid clinical trials in Florence, Alabama.
- Sponsor
- Mast Therapeutics, Inc.
- Study ID
- NCT00337389
- Phase
- PHASE3
- Status
- Unknown
Conditions
- Colon Cancer
- Metastatic Colorectal Cancer
- Rectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 5- Fluorouracil (5-FU) — DRUG
- bevacizumab (Avastin) — DRUG
- Leucovorin — DRUG
- CoFactor (ANX-510) — DRUG
Study Details
To compare the progression-free survival time (PFS) in patients treated with 5-FU modulated with CoFactor (plus bevacizumab) to 5-FU modulated with leucovorin (plus bevacizumab) in patients with Metastatic Colorectal Cancer.
Key Dates
- First listed
- Jun 16, 2006
- Start date
- May 31, 2006
- Status verified
- Nov 2007
Study Design
- Enrollment
- 1,200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 1CoFactor, 5-FU, Avastin
- Active Comparator: 2Leucovorin, 5-FU, Avastin
Primary Outcome Measure
Progression Free Survival
Locations (46)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Center In | Florence | Alabama | - | - |
| Research Center In | Anaheim | California | - | - |
| Research Center In | Apple Valley | California | - | - |
| Research Center In | Beverly Hills | California | - | - |
| Research Center In | Irvine | California | - | - |
| Research Center In | Mission Hills | California | - | - |
| Research Center In | Poway | California | - | - |
| Research Center In | Rancho Mirage | California | - | - |
| Mercy General Hospital | Sacramento | California | 95819 | - |
| Research Center In | Sacramento | California | - | - |
| Research Center In | San Diego | California | - | - |
| Research Site In | San Diego | California | - | - |
| Research Center In | Vista | California | - | - |
| Research Center In | Boynton Beach | Florida | - | - |
| Research Center In | Merritt Island | Florida | - | - |
| Research Center In | Port Saint Lucie | Florida | - | - |
| Research Center In | Tarpon Springs | Florida | - | - |
| Research Center In | Gurnee | Illinois | - | - |
| Research Center In | Joliet | Illinois | - | - |
| Research Center In | Skokie | Illinois | - | - |
| Research Center In | Indianapolis | Indiana | - | - |
| Research Center In | Wichita | Kansas | - | - |
| Research Center In | Hazard | Kentucky | - | - |
| Research Center In | Baltimore | Maryland | - | - |
| Research Center In | Flint | Michigan | - | - |
| Research Center In | Free Soil | Michigan | - | - |
| Research Center In | Grand Rapids | Michigan | - | - |
| Research Center In | Port Huron | Michigan | - | - |
| Research Center In | Jackson | Mississippi | - | - |
| Research Center In | Henderson | Nevada | - | - |
| Research Center In | Las Vegas | Nevada | - | - |
| Research Center In | Reno | Nevada | - | - |
| Research Center In | Cherry Hill | New Jersey | - | - |
| Research Center In | Farmington | New Mexico | - | - |
| Research Center In | East Setauket | New York | - | - |
| Research Center In | Greenville | North Carolina | - | - |
| Research Center In | Middletown | Ohio | - | - |
| Research Center In | Cranston | Rhode Island | - | - |
| Research Center In | Charleston | South Carolina | - | - |
| Research Center In | Columbia | South Carolina | - | - |
| Research Center In | Chattanooga | Tennessee | - | - |
| Research Center In | Collierville | Tennessee | - | - |
| Research Center In | Fort Worth | Texas | - | - |
| Research Center In | Ogden | Utah | - | - |
| Research Center In | Lacey | Washington | - | - |
| Research Center In | Walla Walla | Washington | - | - |
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