NCT04207255

Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II study of the investigational drug opaganib. Patients with metastatic castration resistant prostate cancer (mCRPC) who have experienced disease progression while receiving abiraterone or enzalutamide will receive Opaganib at either 250 mg or 500 mg by mouth twice a day continuously. Patients will continue on study drug until the development of progressive disease, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Opaganib	500mg of Opaganib orally twice a day continuously.
DRUG	Abiraterone	IV as directed by SOC
DRUG	Enzalutamide	IV as directed by SOC
DRUG	Opaganib	250mg of Opaganib orally twice a day continuously.

Timeline

• Start date: 2020-03-27
• Primary completion: 2023-08-31
• Completion: 2024-07-31
• First posted: 2019-12-20
• Last updated: 2024-09-25
• Results posted: 2024-09-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study