Trials / Completed
CompletedNCT01792687
Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN 509 in Combination With Abiraterone Acetate
Phase Ib, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Ascending Doses of ARN-509 in Combination With Abiraterone Acetate in Patients With Metastatic Castrate Resistant Prostate Cancer (CRPC)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Aragon Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase Ib, open label study of ARN-509 administered in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARN-509 | Dose-escalation: 120 milligram (mg), 180 mg, 240 mg, oral, daily |
| DRUG | Abiraterone acetate | 1,000 mg, oral, daily |
| DRUG | Prednisone | 5 mg, oral, daily |
Timeline
- Start date
- 2013-02-05
- Primary completion
- 2014-05-10
- Completion
- 2024-02-13
- First posted
- 2013-02-15
- Last updated
- 2025-03-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01792687. Inclusion in this directory is not an endorsement.