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Also known as ANX-510
CoFactor · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | CoFactor, 5-FU |
| 2 | ACTIVE_COMPARATOR | Leucovorin, 5-FU |
| Name | Type | Description |
|---|---|---|
| CoFactor | DRUG | - |
| 5-FU | DRUG | - |
| Leucovorin | DRUG | - |
| CoFactor and 5FU | DRUG | - |
Inclusion Criteria: * Have surgically incurable, confirmed metastatic colon or rectal adenocarcinoma. * Be male or non-pregnant, non-lactating female subjects ≥ 18 years of age. * If female, and of childbearing potential, agree to use adequate contraception (as deemed by the investigator) throughou...
CoFactor is being studied for use in colon cancer, specifically in patients with metastatic colorectal cancer. It is an investigational small molecule developed by Savara, Inc. and has been evaluated in Phase 2 clinical trials. It has not been approved by the FDA for commercial use.
CoFactor is being developed by Savara, Inc., which trades on the Nasdaq under the ticker symbol SVRA. The company has sponsored Phase 2 clinical trials of CoFactor in metastatic colorectal cancer. Savara is the developer of record for this investigational oncology asset.
CoFactor is in Phase 2 clinical development. Two Phase 2 trials have been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA. Further clinical development would be required before any regulatory submission could be considered.
CoFactor has been studied in two completed Phase 2 trials: NCT00235898, which enrolled 300 patients with metastatic colorectal cancer across India, Poland, Romania, Serbia, and the United Kingdom, and NCT00081627, which enrolled 48 patients in the United States and Serbia and Montenegro. Both trials are now completed.
A total of 348 patients were enrolled across the two completed Phase 2 trials of CoFactor. NCT00235898 enrolled 300 patients, and NCT00081627 enrolled 48 patients. Both studies were randomized, active-controlled trials in adults with metastatic colorectal cancer.