Galeterone Alone or Combined with Gemcitabine for the Treatment of Refractory Metastatic Pancreatic Adenocarcinoma
- 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
- Histologic or cytologic diagnosis of pancreatic adenocarcinoma
- Measurable metastatic disease documented by computed tomography/magnetic resonance imaging (CT/MRI) at least 1cm in greatest dimension
- 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
- 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 =< 14 days prior to randomization)
- Platelet count >= 100,000/mm^3 (100 X 10^9/L) (obtained =< 14 days prior to randomization)
- Hemoglobin (Hgb) >= 8 g/dL (obtained =< 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
- 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 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 electrocardiogram (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
- 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
I. Response rate, defined as the percentage of patients who achieve partial response or complete response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 8 weeks after treatment.
I. Progression-free Survival, defined as time from trial assignment to the occurrence of one of the following: confirmed disease progression using RECIST 1.1 criteria, or death from any cause (whichever occurs first).
II. Overall Survival, defined as time from trial assignment to time of death from any cause.
I. Frequency and intensity of adverse events (AEs).
OUTLINE: Patients are randomized to 1 of 2 trials.
TRIAL A: Patients receive galeterone orally (PO) once daily (QD) on day 1 through day 28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
TRIAL B: Patients receive galeterone PO QD on day 1 through day 28. Patients also receive gemcitabine intravenously (IV) over 30 minutes on days 1, 8 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After the completion of study treatment, patients are followed up at 30 days and every 12 weeks afterwards.
Trial Phase Phase II
Trial Type Treatment
University of Maryland / Greenebaum Cancer Center
- Primary ID 1911GCCC
- Secondary IDs NCI-2020-00208
- Clinicaltrials.gov ID NCT04098081