Galeterone treatment for advanced pancreatic cancer

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

This study is testing if a new drug called galeterone, alone or with chemotherapy, can help people with advanced pancreatic cancer who have not responded to previous treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT04098081 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the effectiveness of galeterone, an investigational androgen receptor inhibitor, in treating patients with metastatic pancreatic adenocarcinoma. Participants will receive galeterone alone or in combination with the chemotherapy drug gemcitabine. The study aims to assess the safety and efficacy of this treatment approach in patients who have previously undergone systemic therapy and are experiencing disease progression. The trial will involve regular clinic visits for monitoring and assessment of treatment response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of metastatic pancreatic adenocarcinoma who have received at least two lines of prior systemic therapy.

Not a fit: Patients who have not received prior systemic therapy or those with a performance status greater than 2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced pancreatic cancer.

How similar studies have performed: While galeterone has shown anti-cancer activity in laboratory settings, this specific approach in pancreatic cancer is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Baltimore, Maryland

• University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Aaron Ciner, MD — University of Maryland, Baltimore
• Study coordinator: Aaron Ciner, MD

Conditions Advanced Pancreatic Cancer; pancreatic cancer