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

Assess the effectiveness of galeterone in advanced pancreatic adenocarcinoma

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 \ 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 \