Clinical Trials /

1911GCCC: Galeterone or Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma

NCT04098081

Description:

Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 1911GCCC: Galeterone or Galeterone With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma
  • Official Title: 1911GCCC:Two Parallel, Single-arm, Open Label, Phase 2 Trials of Galeterone Alone or Galeterone Combined With Gemcitabine for Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Standard Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: 1911GCCC
  • NCT ID: NCT04098081

Conditions

  • Advanced Pancreatic Cancer

Interventions

DrugSynonymsArms
galeteronegaleterone
Gemcitabinegaleterone+gemcitabine

Purpose

Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma

Detailed Description

      This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of galeterone, an investigational drug, in pancreatic cancer.

      The FDA (the U.S. Food and Drug Administration) has not approved galeterone for pancreatic
      cancer. Galeterone is an androgen receptor inhibitor that showed anti-cancer activity in
      pancreatic cancer in research lab. In this study, the investigator is interested in
      evaluating galeterone alone or in combination with chemotherapy in treating pancreatic
      cancer.
    

Trial Arms

NameTypeDescriptionInterventions
galeteroneExperimentalgaleterone orally once daily
  • galeterone
galeterone+gemcitabineExperimentaldaily dose galeterone and weekly dose of gemcitabine
  • galeterone
  • Gemcitabine

Eligibility Criteria

        Inclusion Criteria:

          1. Ability to understand and willingness to sign a written informed consent document

          2. Agree to comply with the study requirements and agrees to come to the clinic/hospital
             for required study visits

          3. 18 years of age or order

          4. Histologic or cytologic diagnosis of pancreatic adenocarcinoma

          5. Measurable metastatic disease documented by CT/MRI at least 1cm in greatest dimension

          6. Have received 2 lines of prior systemic therapy; those patients must demonstrate
             continued disease progression (RECIST 1.1) and must not have received chemotherapy for
             at least 4 weeks prior to trial assignment;

          7. ECOG performance status must be 0-2 (Appendix A).

          8. All participants (male and female) with reproductive potential must practice an
             effective method of contraception while on this study in order to minimize risks to
             fetuses.

          9. Men and women of all ethnic groups are eligible for this trial.

         10. Able to swallow up to six pills and retain oral medication

         11. Expected life expectancy of more than 12 weeks.

         12. Patient has adequate bone marrow function as demonstrated by the following blood

               -  counts at Baseline (obtained ≤14 days prior to randomization):

               -  Absolute neutrophil count (ANC) ≥1.5 × 109/L;

               -  Platelet count ≥100,000/mm3 (100 × 109/L);

               -  Hemoglobin (Hgb) ≥ 8 g/dL.

         13. Patient has adequate organ functions at baseline (obtained ≤14 days prior to
             randomization):

               -  AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal range (ULN),

               -  Total bilirubin ≤ 1.2mg/dl

               -  Serum creatinine within normal limits or calculated clearance ≥50 mL/min. If
                  using creatinine clearance, actual body weight should be used for calculating
                  creatinine clearance (eg, using the Cockroft-Gault formula). For patients with a
                  Body Mass Index (BMI) >30 kg/m2, adjusted body weight should be used instead.

         14. Patients with well controlled oligo brain metastasis are eligible Ability to
             understand and willingness to sign a written informed consent document.

         15. Agree to comply with the study requirements and agrees to come to the clinic/hospital
             for required study visits.

         16. 18 years of age or order.

         17. Histologic or cytologic diagnosis of stage IV pancreatic adenocarcinoma.

         18. Measurable disease per RECIST 1.1 criteria.

         19. Have received 2 lines of prior systemic therapy; those patients must demonstrate
             continued disease progression (RECIST 1.1) and must not have received chemotherapy for
             at least 4 weeks prior to trial assignment.

         20. ECOG performance status must be 0-2 (Appendix A).

         21. All participants (male and female) with reproductive potential must agree to be
             abstinent or practice an effective method of contraception while on this study in
             order to minimize risks to fetuses.

         22. Men and women of all ethnic groups are eligible for this trial.

         23. Able to swallow up to six pills and retain oral medication.

         24. Expected life expectancy of more than 12 weeks.

        Exclusion Criteria:

          1. Participation in another clinical trial involving experimental therapy for pancreatic
             adenocarcinoma within 4 weeks prior to enrollment or simultaneous participation in a
             study involving investigational treatment.

          2. Prior anti-cancer therapy:

               -  Prior treatment with galeterone, or anti-androgens.

               -  Prior radiation therapy within 4 weeks (if single fraction of radiotherapy within
                  2 weeks).

          3. Concurrent use of other anti-cancer agents.

          4. Major surgery within 4 weeks prior to randomization.

          5. The following medical conditions:

               -  New York Heart Association Class III or IV congestive heart failure.

               -  Myocardial infarction/unstable angina (within the 6 months prior to
                  randomization).

               -  History of clinically significant ventricular arrhythmias (e.g., ventricular
                  tachycardia).

               -  History of long QT syndrome, Mobitz II second or third degree heart block without
                  a permanent pacemaker in place.

               -  Bradycardia as defined by heart rate of <50 beats/minute at Screening ECG.

               -  History of chronic or active Hepatitis B or Hepatitis C or other known chronic
                  liver disease. Patients recovered from hepatitis are not excluded from the study.

               -  Known human immunodeficiency virus (HIV) infection.

               -  Uncontrolled hypertension (defined as systolic blood pressure > 170 mmHg or
                  diastolic blood pressure of > 105 mmHg measured on at least two occasions, two
                  weeks apart) despite acceptable anti-hypertension therapy.

               -  Hypotension (defined as systolic blood pressure <90 mmHg).

               -  History of adrenal insufficiency or hyperaldosteronism.

               -  Gastrointestinal disorders or gastric bypass surgery, with the exception of
                  pancreatic cancer and its complications, including lap bands that could interfere
                  with the absorption of galeterone.

               -  Serious active infections requiring systemic treatment or nonmalignant medical
                  illnesses that are uncontrolled.

               -  History of seizure or any condition or concomitant use of any medication that may
                  predispose to seizure or lower the seizure threshold.

               -  History of loss of consciousness or transient ischemic attack within 12 months of
                  randomization.

               -  History of (in the past 5 years) other malignancy, other than curatively treated
                  nonmelanomatous skin cancer and superficial transitional cell carcinoma of the
                  bladder.

               -  Cranial/spinal epidural disease.

               -  The patient has known allergy to any of the treatment components.

          6. Any physical or mental condition or social situation that, in the opinion of the
             Investigator, may interfere with the patient's ability to comply with the trial
             procedures, confound the ability to interpret data from the study or places the
             patient at unacceptable risk if he participates in this study.

          7. Current alcohol abuse or illicit drug use.

          8. Since the teratogenic potential of this combination is currently unknown, females who
             are pregnant or lactating are excluded.

          9. Females at reproductive age must have a negative urine pregnancy test prior to entry
             to this study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:response rate
Time Frame:8 weeks post treatment
Safety Issue:
Description:number of patients whose disease shrink during treatment

Secondary Outcome Measures

Measure:progression-free survival
Time Frame:From date of randomization until the date of first documented progression, assessed up to 100 months
Safety Issue:
Description:time for galeterone to control the disease
Measure:overall survival
Time Frame:From date of randomization until the date of death from any cause, assessed up to 100 months
Safety Issue:
Description:total life expectancy

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Maryland, Baltimore

Trial Keywords

  • pancreatic cancer

Last Updated

December 12, 2019