drugset / Trial / NCT02913196
Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC
Phase 1
Completed
16 enrolled
Weill Medical College of Cornell University
Janssen Scientific Affairs, LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multi-center, Phase I study of apalutamide in combination with abiraterone acetate, docetaxel and prednisone in patients with metastatic mastrate resistant prostate cancer (mCRPC). This study is designed to determine the dose that apalutamide can be administered safely in combination with abiraterone acetate, docetaxel and prednisone.
Timeline
- Start
- 2016-12-30
- Primary completion
- 2021-06-30
- Completion
- 2025-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apalutamide | Small molecule | 120 mg | Oral |
| Subject | Apalutamide | Small molecule | 180 mg | Oral |
| Subject | Apalutamide | Small molecule | 240 mg | Oral |
| Background | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |