Clinical Trials /

Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

NCT04207255

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Addition of Opaganib to Androgen Antagonists in Patients With mCRPC
  • Official Title: A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone

Clinical Trial IDs

  • ORG STUDY ID: Pro00095537
  • SECONDARY ID: 1P01CA203628-01
  • SECONDARY ID: 103193
  • NCT ID: NCT04207255

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
OpaganibCohort 2: Opaganib with abiraterone
AbirateroneCohort 1a: Opaganib with abiraterone
EnzalutamideCohort 1b: Opaganib with enzalutamide
OpaganibCohort 1a: Opaganib with abiraterone

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Cohort 2: Opaganib with abirateroneExperimental
  • Opaganib
  • Abiraterone
Cohort 3: Opaganib with enzalutamideExperimental
  • Opaganib
  • Enzalutamide
Cohort 1a: Opaganib with abirateroneExperimental
  • Abiraterone
  • Opaganib
Cohort 1b: Opaganib with enzalutamideExperimental
  • Enzalutamide
  • Opaganib

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease control status
Time Frame:113 days
Safety Issue:
Description:Stable disease or better according to Prostate Cancer Working Group 3 (PCWG3) criteria after four cycles of treatment

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Medical University of South Carolina

Trial Keywords

  • Yeliva
  • ABC294640

Last Updated

August 3, 2020