drugset / Trial / NCT04207255

Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

NCT04207255

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-03-27
Primary completion
2023-08-31
Completion
2024-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ABC294640 Small molecule 250 mg Oral
Subject ABC294640 Small molecule 500 mg Oral
Background Abiraterone acetate Small molecule Intravenous
Background Enzalutamide Other / unclassified Intravenous

Indications