drugset / Trial / NCT03074032

Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer

NCT03074032 ↗

Phase 1 Completed 17 enrolled Avionco LLC
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

EvaluationDrugModalityDoseRoute
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