Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

NCT04207255 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: Pro000955371P01CA203628-01103193
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 2

Brief 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

Prostate Cancer

Keywords

Yeliva; ABC294640; 103193

Outcome Measures

Primary Outcomes (1)

• Disease Control Status

  Stable disease or better according to Prostate Cancer Working Group 3 (PCWG3) criteria after four cycles of treatment

  113 days

Study Arms (4)

Cohort 2: Opaganib with abiraterone

EXPERIMENTAL

Drug: Opaganib; Drug: Abiraterone

Cohort 3: Opaganib with enzalutamide

EXPERIMENTAL

Drug: Opaganib; Drug: Enzalutamide

Cohort 1a: Opaganib with abiraterone

EXPERIMENTAL

Drug: Abiraterone; Drug: Opaganib

Cohort 1b: Opaganib with enzalutamide

EXPERIMENTAL

Drug: Enzalutamide; Drug: Opaganib

Interventions

Opaganib DRUG

500mg of Opaganib orally twice a day continuously.

Cohort 2: Opaganib with abiraterone; Cohort 3: Opaganib with enzalutamide

Abiraterone DRUG

IV as directed by SOC

Cohort 1a: Opaganib with abiraterone; Cohort 2: Opaganib with abiraterone

Enzalutamide DRUG

IV as directed by SOC

Cohort 1b: Opaganib with enzalutamide; Cohort 3: Opaganib with enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have mCRPC. Each patient must have:
• Tissue diagnosis documented by pathology report, or clinic note attesting to same.
• Radiographically-demonstrated metastases
• Patients must have adenocarcinoma, or ductal carcinoma, or combinations of these two entities
• Voluntary, signed and dated, institutional review board (IRB)-approved informed consent form in accordance with regulatory and institutional guidelines.
• Documented progression during treatment with enzalutamide or abiraterone, as determined by the enrolling investigator.
• Testosterone level documented to be less than 50ng/
• years of age or older.
• ECOG performance status of 0-2.
• Acceptable liver function:
• Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 1 baseline)
• AST (SGOT) \& ALT (SGPT) ≤ 3 x ULN (CTCAE Grade 1 baseline)
• Subjects with Gilbert's syndrome may be included if the total bilirubin is \<3x ULN and the direct bilirubin is within normal limits
• Acceptable kidney function indicated by serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
• Acceptable hematologic status:

You may not qualify if:

• New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
• Underlying psychiatric disorder requiring hospitalization within the last two years.
• Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
• Active, uncontrolled bacterial, viral or fungal infection, requiring systemic therapy.
• Treatment with radiation therapy, surgery, or investigational therapy within 28 days prior to registration.
• Unwillingness or inability to comply with procedures required in this protocol.
• Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.
• Patients who are receiving coumadin, apixaban, argatroban or rivaroxaban. Patients who are receiving other drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped at least 7 days or 5 half-lives (whichever is longer) before starting treatment with opaganib may be treated on this study with careful monitoring for toxic effects or loss of efficacy of the relevant drug. A list of commonly used drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes with the half-life of each drug identified, is included as an Appendix C.
• Patients who are currently participating in any other clinical trial of an investigational product.
• Other primary malignancy requiring systemic treatment within past 5 years except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer.
• Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
• Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 20322, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

3-(4-chlorophenyl)-adamantane-1-carboxylic acid (pyridin-4-ylmethyl)amide; abiraterone; enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Alan Brisendine
• Organization: Medical University of South Carolina

brisend@musc.edu

(843) 792-9007

Study Officials

• Michael Lilly, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 20, 2019
• Study Start: March 27, 2020
• Primary Completion: August 31, 2023
• Study Completion: July 31, 2024
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)