Trials / No Longer Available
No Longer AvailableNCT03523338
An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer
An Open-Label Expanded Access Protocol for Apalutamide Treatment of Subjects With Non Metastatic Castration-Resistant Prostate Cancer
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Aragon Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to collect additional safety data until apalutamide is commercially available for participants with non-metastatic castrate-resistant prostate cancer (NM-CRPC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apalutamide | Participants will receive apalutamide 240 mg orally once daily. |
| DRUG | ADT (Standard of Care) | Participants who did not undergo surgical castration, should receive and remain on a stable regimen of ADT according to local standard of care. |
Timeline
- First posted
- 2018-05-14
- Last updated
- 2025-12-10
Locations
12 sites across 3 countries: Brazil, Colombia, Mexico
Source: ClinicalTrials.gov record NCT03523338. Inclusion in this directory is not an endorsement.