At a glance
ClinicalIndex Comparison Record- ✓Metastatic castration-resistant prostate cancer (mCRPC) with tissue-confirmed adenocarcinoma or ductal carcinoma and radiographic metastases
- ✓Documented progression during treatment with enzalutamide or abiraterone as determined by investigator
- ✓Castrate testosterone level <50 ng/dL
- ✓Age 18 years or older
- ✕New York Heart Association Class III or IV cardiac disease, recent myocardial infarction (within 6 months), unstable arrhythmia, or ECG evidence of ischemia
- ✕Psychiatric disorder requiring hospitalization within the past 2 years
- ✕Clinically significant neurological disorder such as Parkinson's disease, dementia, or multiple sclerosis
- ✕Active uncontrolled bacterial, viral, or fungal infection requiring systemic therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone
In Brief
A Phase 2 clinical trial evaluating Opaganib, Abiraterone, and 1 other intervention for Prostate Cancer. Completed, enrolled 69 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
500mg of Opaganib orally twice a day continuously.
IV as directed by SOC
IV as directed by SOC
250mg of Opaganib orally twice a day continuously.