Overview

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

Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
0
Participant gender:
All
Summary
Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Maryland, Baltimore
Treatments:
3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene
Gemcitabine
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.