- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207255
Addition of Opaganib to Androgen Antagonists in Patients With mCRPC
January 31, 2024 updated by: Medical University of South Carolina
A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alan Brisendine
- Phone Number: 843-792-9007
- Email: hcc-clinical-trials@musc.edu
Study Contact Backup
- Name: Michael Lilly, MD
- Phone Number: 843-792-4271
- Email: lillym@musc.edu
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 20322
- Emory University
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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/
- 18 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:
- Absolute neutrophil count ≥ 1000 cells/mm3,
- Platelet count ≥ 75,000 (plt/mm3) (CTCAE Grade 1 baseline)
- Hemoglobin ≥ 9.0 g/dL.
- Fasting blood glucose of <165mg/dL
- Urinalysis: no clinically significant abnormalities
- International normalized ratio (INR) ≤1.7
- Well-controlled blood pressure as determined by the treating investigator
- Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 2: Opaganib with abiraterone
|
500mg of Opaganib orally twice a day continuously.
IV as directed by SOC
250mg of Opaganib orally twice a day continuously.
|
Experimental: Cohort 3: Opaganib with enzalutamide
|
500mg of Opaganib orally twice a day continuously.
250mg of Opaganib orally twice a day continuously.
IV as directed by SOC
|
Experimental: Cohort 1a: Opaganib with abiraterone
|
500mg of Opaganib orally twice a day continuously.
IV as directed by SOC
250mg of Opaganib orally twice a day continuously.
|
Experimental: Cohort 1b: Opaganib with enzalutamide
|
500mg of Opaganib orally twice a day continuously.
250mg of Opaganib orally twice a day continuously.
IV as directed by SOC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control status
Time Frame: 113 days
|
Stable disease or better according to Prostate Cancer Working Group 3 (PCWG3) criteria after four cycles of treatment
|
113 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Lilly, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 27, 2020
Primary Completion (Actual)
August 31, 2023
Study Completion (Estimated)
March 31, 2024
Study Registration Dates
First Submitted
November 25, 2019
First Submitted That Met QC Criteria
December 19, 2019
First Posted (Actual)
December 20, 2019
Study Record Updates
Last Update Posted (Actual)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 31, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00095537
- 1P01CA203628-01 (U.S. NIH Grant/Contract)
- 103193 (Other Identifier: MUSC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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