Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00106301 | Continuation Trial Evaluating the Tolerability and Activity of FK228 in Patients That Completed Prior Study With FK228 | PHASE2 | COMPLETED | 2 | — | — | Apr 1, 2004 | Sep 1, 2006 | Nov 18, 2019 | 5 | United States, United Kingdom |
| NCT00106613 | A Research Study for Patients With Metastatic Renal Cell Carcinoma | PHASE2 | COMPLETED | 30 | — | — | May 1, 2003 | Aug 1, 2004 | Oct 18, 2019 | 3 | United States |
| 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...