Approval Probability
TA Base Rate
Adjusted LOA
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FK228 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| FK228 (romidepsin) | EXPERIMENTAL | romidepsin |
| Name | Type | Description |
|---|---|---|
| FK228 (romidepsin) | DRUG | Patients were continued at the same dose of romidepsin as in the previous study, which could have been 13 mg/m2 or a reduced dose of 10 mg/m2, administered intravenously over 4 hours on Days 1, 8, and 15 of each 28-day cycle. |
Inclusion Criteria: * Patient has completed 6 cycles of therapy in a prior Fujisawa-sponsored FK228 clinical trial; * Patient has immediate past participation (not to exceed 21 days from Day 15 of cycle 6 in the previous study) in a prior Fujisawa-sponsored FK228 clinical trial; * Patient has demon...
FK228 is an investigational small molecule being studied for the treatment of carcinoma, renal cell, including metastatic renal cell carcinoma. It is in Phase 2 clinical development and is not approved by the FDA. The drug is being evaluated for its activity and tolerability in patients with these conditions.
FK228 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with renal cell carcinoma.
FK228 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 2 trials have been completed, with a total enrollment of 32 patients, but no active trials are currently ongoing.
FK228 has been studied in two completed Phase 2 clinical trials. NCT00106301 evaluated tolerability and activity in patients who completed prior FK228 studies, enrolling 2 patients with renal cell carcinoma and prostatic neoplasms. NCT00106613 studied 30 patients with metastatic renal cell carcinoma in the United States.
FK228 is also known as romidepsin, a histone deacetylase inhibitor. The drug is being investigated for its potential role in treating renal cell carcinoma. It is important to note that while romidepsin is approved for other indications, FK228 remains investigational for this specific use.