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Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

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ClinicalTrials.gov Identifier: NCT04207255
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : October 27, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Opaganib Drug: Abiraterone Drug: Enzalutamide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone
Actual Study Start Date : March 27, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Cohort 2: Opaganib with abiraterone Drug: Opaganib
500mg of Opaganib orally twice a day continuously.

Drug: Abiraterone
IV as directed by SOC

Experimental: Cohort 3: Opaganib with enzalutamide Drug: Opaganib
500mg of Opaganib orally twice a day continuously.

Drug: Enzalutamide
IV as directed by SOC

Experimental: Cohort 1a: Opaganib with abiraterone Drug: Abiraterone
IV as directed by SOC

Drug: Opaganib
250mg of Opaganib orally twice a day continuously.

Experimental: Cohort 1b: Opaganib with enzalutamide Drug: Enzalutamide
IV as directed by SOC

Drug: Opaganib
250mg of Opaganib orally twice a day continuously.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Voluntary, signed and dated, institutional review board (IRB)-approved informed consent form in accordance with regulatory and institutional guidelines.
  3. Documented progression during treatment with enzalutamide or abiraterone, as determined by the enrolling investigator.
  4. Testosterone level documented to be less than 50ng/
  5. 18 years of age or older.
  6. ECOG performance status of 0-2.
  7. 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
  8. Acceptable kidney function indicated by serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
  9. Acceptable hematologic status:

    • Absolute neutrophil count ≥ 1000 cells/mm3,
    • Platelet count ≥ 75,000 (plt/mm3) (CTCAE Grade 1 baseline)
    • Hemoglobin ≥ 9.0 g/dL.
  10. Fasting blood glucose of <165mg/dL
  11. Urinalysis: no clinically significant abnormalities
  12. International normalized ratio (INR) ≤1.7
  13. Well-controlled blood pressure as determined by the treating investigator
  14. Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.

Exclusion Criteria:

  1. 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.
  2. Underlying psychiatric disorder requiring hospitalization within the last two years.
  3. Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
  4. Active, uncontrolled bacterial, viral or fungal infection, requiring systemic therapy.
  5. Treatment with radiation therapy, surgery, or investigational therapy within 28 days prior to registration.
  6. Unwillingness or inability to comply with procedures required in this protocol.
  7. Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.
  8. 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.
  9. Patients who are currently participating in any other clinical trial of an investigational product.
  10. 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.
  11. Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
  12. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04207255


Contacts
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Contact: Alan Brisendine 843-792-9007 hcc-clinical-trials@musc.edu
Contact: Michael Lilly, MD 843-792-4271 lillym@musc.edu

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 20322
Contact: Wilena Sessions       wsessio@emory.edu   
Principal Investigator: Omer Kucuk, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Alan Brisendine    843-792-9007    hcc-clinical-trials@musc.edu   
Principal Investigator: Michael Lilly, MD         
Sponsors and Collaborators
Medical University of South Carolina
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael Lilly, MD Medical University of South Carolina
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04207255    
Other Study ID Numbers: Pro00095537
1P01CA203628-01 ( U.S. NIH Grant/Contract )
103193 ( Other Identifier: MUSC )
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: October 27, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of South Carolina:
Yeliva
ABC294640
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases