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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01664728 | An Expanded Access Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer Who Have Completed Clinical Study COU-AA-001 | PHASE1 | COMPLETED | 54 | — | — | Apr 1, 2007 | Sep 1, 2012 | Apr 19, 2013 | 1 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| Abiraterone acetate | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Abiraterone acetate | DRUG | Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily |
| Glucocorticoid | DRUG | prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily |
Inclusion Criteria: * Completed 12 cycles of abiraterone acetate under study COU-AA-001 * Last dose of abiraterone acetate within 14 days prior to treatment in this study * Demonstrates potential to gain clinical benefit with continued abiraterone acetate treatment * Serum potassium level \>=3.5 mm...