NCT03074032

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

Phase I Open-label Single- and Multiple-ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONC1-0013B in Patients With Progressive Metastatic Castration-resistant Prostate Cancer (mCRPC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Avionco LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	ONC1-0013B	ONC1-0013B per os daily

Timeline

• Start date: 2014-06-30
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2017-03-08
• Last updated: 2017-07-11

Locations

2 sites across 1 country: Russia