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

May 15, 2023 updated by: University of Maryland, Baltimore

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

Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

58

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

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
          • Aaron Ciner, MD
          • Phone Number: 410-328-6505

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:

  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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: galeterone
galeterone orally once daily
Drug: galeterone
Therapeutic
Experimental: galeterone+gemcitabine
daily dose galeterone and weekly dose of gemcitabine
Drug: galeterone
Therapeutic
Drug: Gemcitabine
Therapeutic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

  • Principal Investigator: Aaron Ciner, MD, University of Maryland, Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 12, 2019

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 19, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1911GCCC

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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