drugset / Trial / NCT03074032
Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a PhaseI, open-label study, Dose-Escalation Study, where tolerated doses will be escalated to the next doses with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients. Tumor assessment and PSA values will be evaluated during the study as an additional point.
Timeline
- Start
- 2014-06-30
- Primary completion
- 2017-04
- Completion
- 2017-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ONC1-0013B | Unknown | 40 mg | Oral |
| Subject | ONC1-0013B | Unknown | 80 mg | Oral |
| Subject | ONC1-0013B | Unknown | 160 mg | Oral |
| Subject | ONC1-0013B | Unknown | 320 mg | Oral |