Galeterone Combined with Gemcitabine for the Treatment of Refractory Metastatic Pancreatic Adenocarcinoma

Inclusion Criteria

• Ability to understand and willingness to sign a written informed consent document
• Agree to comply with the study requirements and agrees to come to the clinic/hospital for required study visits
• 18 years of age or order
• Histologic or cytologic diagnosis of pancreatic adenocarcinoma
• Measurable disease documented by computed tomography/magnetic resonance imaging (CT/MRI) per RECIST version 1.1
• Have received at least 1 line of prior systemic therapy; and must not have received systemic therapy for at least 4 weeks prior to enrollment
• Eastern Cooperative Oncology Group (ECOG) performance status must be 0-2
• 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
• Men and women of all ethnic groups are eligible for this trial
• Able to swallow up to six pills and retain oral medication
• Expected life expectancy of more than 12 weeks
• Absolute neutrophil count (ANC) >= 1.5 × 10^9/L (obtained within 14 days prior to randomization)
• Platelet count >= 100,000/mm^3 (100 X 10^9/L) (obtained within 14 days prior to randomization)
• Hemoglobin (Hgb) >= 8 g/dL (obtained within 14 days prior to randomization)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X upper limit of normal range (ULN) (obtained =< 14 days prior to randomization)
• Total bilirubin =< 1.2 mg/dl (obtained =< 14 days prior to randomization)
• Serum creatinine within normal limits or calculated clearance >= 50 mL/min (obtained =< 14 days prior to randomization): * If using creatinine clearance, actual body weight should be used for calculating creatinine clearance (eg, using the Cockcroft-Gault formula). For patients with a body mass index (BMI) > 30 kg/m^2, adjusted body weight should be used instead
• Patients with well controlled oligo brain metastasis are eligible. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

• 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
• 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)
• Concurrent use of other anti-cancer agents
• Major surgery within 4 weeks prior to randomization
• 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 enrollment) * 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 * Active Hepatitis B (presence of hepatitis B surface antigen and/or hepatitis B virus core antibody [anti-HBcAb] with detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA] >= 10 IU/mL), or Hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of anti-HBc and the absence of HBsAg are eligible). Patients positive for hepatitis C antibody are eligible only if the polymerase chain reaction is negative for HCV ribonucleic acid (RNA) * Known human immunodeficiency virus (HIV) infection unless they meet the following criteria: CD4+ T-cell count >= 350 cells/uL, undetectable viral load. Patients must also be on anti-retroviral therapy and not have had an opportunistic infection within the prior 12 months * 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 cerebrovascular accident including transient ischemic attack within 6 months of enrollment * History of another primary malignancy except for: ** Malignancy treated with curative intent and no known active disease for at least 3 years ** Adequately treated non-melanomatous skin cancer ** Adequately treated superficial transitional cell carcinoma of the bladder or carcinoma-in-situ without evidence of disease * Cranial/spinal epidural disease * The patient has known allergy to any of the treatment components
• 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
• Current alcohol abuse or illicit drug use
• Since the teratogenic potential of this combination is currently unknown, females who are pregnant or lactating are excluded
• Females at reproductive age must have a negative urine pregnancy test prior to entry to this study