Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CoFactor and 5FU · 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 an investigational small molecule being studied for use in colon cancer and rectal cancer, specifically in patients with metastatic colorectal cancer. It has also been evaluated in healthy adult subjects in a Phase 1 clinical trial. CoFactor is not approved by the FDA and remains in clinical development.
CoFactor is being developed by Savara, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SVRA. Savara is conducting clinical trials to evaluate the safety and efficacy of CoFactor in patients with metastatic colorectal cancer.
CoFactor is in Phase 1 clinical development. While two completed trials for metastatic colorectal cancer were Phase 2 studies, the most recent trial, NCT00663481, was a Phase 1 study in healthy adults. CoFactor is investigational and has not received FDA approval.
CoFactor has been studied in three completed clinical trials. NCT00081627 and NCT00235898 were Phase 2 trials in patients with metastatic colorectal cancer, enrolling 48 and 300 participants respectively. NCT00663481 was a Phase 1 trial in 15 healthy adults. All trials are completed.
CoFactor is not the same as leucovorin, but it was compared to leucovorin in a clinical trial. NCT00663481 evaluated CoFactor formulations and leucovorin administered intravenously in healthy adult subjects. CoFactor is a separate investigational drug being developed by Savara, Inc.