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Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

NCT04207255 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-09-25

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Michael Lilly, MD · Medical University of South Carolina

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-27
Primary Completion
2023-08-31
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04207255 on ClinicalTrials.gov