Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

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

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper The trial did not meet its primary objective of demonstrating 30% disease control at 113 days. reads as missed primary endpoint PMID 41981710 ↗

release “in advanced prostate cancer at the Medical University of South Carolina (MUSC) and Emory University, the study has met its primary endpoint” reads as met primary endpoint redhillbio.com ↗

release “the study did not meet its primary endpoint in the study arm evaluating opaganib in combination with enzalutamide.” reads as missed primary endpoint redhillbio.com ↗

Publications

• Brown JT, Nazha B, Ferreira AC, Armeson K, Hill EG, Ogretmen B, Mehrotra S, Brisendine A, Magrath G, Plasse TF, Gourdin TS, Kucuk O, Lilly M. Phase II Trial of Opaganib Addition in Metastatic Castration-Resistant Prostate Cancer After Disease Progression on Abiraterone or Enzalutamide. Cancer Med. 2026 Apr;15(4):e71633. doi: 10.1002/cam4.71633.

Drugs

Evaluation	Drug	Modality	Dose	Route
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