Opaganib and Androgen Antagonists for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer

Active:	No
Cancer Type:	Prostate Cancer	NCT ID:	NCT04207255
Trial Phases:	Phase II	Protocol IDs:	103193 (primary) NCI-2020-01752
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	Medical University of South Carolina
NCI Full Details:	http://clinicaltrials.gov/show/NCT04207255

Summary

This phase II trial studies how well opaganib works when added to androgen antagonists in treating patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Opaganib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Testosterone can cause the growth of prostate cancer cells. Androgen antagonists, such as abiraterone and enzalutamide, may help fight prostate cancer by lowering the amount of testosterone made by the body, or by blocking the use of testosterone by the tumor cells. Giving opaganib with androgen antagonists may work better than androgen antagonists alone in treating patients with castration resistant prostate cancer.

Objectives

PRIMARY OBJECTIVE:
I. To measure the proportion of patients with disease control during opaganib (plus abiraterone or enzalutamide) therapy, using a composite metric based on prostate specific antigen (PSA), bone scan, and Response Evaluation Criteria in Solid Tumors (RECIST) measurements per Prostate Cancer Working Group 3 (PCWG3) criteria.

SECONDARY OBJECTIVES:
I. To estimate the overall survival (OS), radiographic progression-free survival (rPFS), and PSA progression-free survival (PSA-PFS) times in patients treated with opaganib (plus abiraterone or enzalutamide).
II. To document the PSA response rate, RECIST response rate, and change in quality of life (QOL) (Functional Assessment of Cancer Therapy- Prostate [FACT-P]) and pain score (Likert Pain Score) in metastatic castration resistant prostate cancer (mCRPC) patients treated with opaganib (plus abiraterone or enzalutamide) after four cycles of treatment.
III. To determine the effects opaganib on regression or progression of mCRPC clones with amplified AR or MYC, identified by serial circulating tumor deoxyribonucleic acid (ctDNA)-based genomic profiling.
IV. To assess safety of opaganib in mCRPC patients, in combination with abiraterone or enzalutamide, gonadotropin releasing hormone receptor (GnRHR) agonist/antagonist (this is the primary objective for the run-in cohort).
V. To monitor changes in numbers or activity of immune cells and myeloid-derived suppressor cells during opaganib therapy (with continued androgen-depleting therapy [ADT]).

OUTLINE:
Patients receive opaganib orally (PO) twice daily (BID). Patients also continue receiving abiraterone or enzalutamide. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 30 months.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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