A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
- Registration Number
- NCT01709734
- Lead Sponsor
- LTN PHARMACEUTICALS, INC.
- Brief Summary
A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.
- Detailed Description
This trial will be split into two parts. The purpose of Part 1 will be to confirm dose and target patient population and Part 2 will be expansion of the dose and patient population selected in Part 1. For eligible patients, there will be an optional extension dosing following the completion of Part 1 or Part 2 of the trial.
Obtaining of informed consent and screening may be performed up to 28 days prior to enrollment. Each patient will be able to receive his specified regimen for 3 consecutive cycles. Each cycle consists of 28 days (approximately 1 mo.). End of Cycle 3 visit assessments will be used to determine outcome and dosing may continue up to an additional 2 weeks until the results of all assessments are obtained. Eligible patients may continue treatment in an optional extension period following the completion of the primary parts of this trial.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 126
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
- Demonstration of progression while on androgen blockade
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
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Depending upon patient prior treatment the following apply:
- Prior treatment with CYP17 inhibitors or AR antagonists (e.g. abiraterone, TAK-700, ARN-509, ketoconazole*, enzalutamide, or galeterone) - Treatment naïve only
- Prior treatment with CYP17 inhibitors (e.g. TAK-700, ketoconazole*) or AR antagonists (e.g. enzalutamide, ARN-509,) or galeterone - abiraterone refractory only
- Prior treatment with CYP17 inhibitors (e.g. abiraterone, TAK-700, ketoconazole*) or AR antagonists (e.g. ARN -509) or galeterone - enzalutamide refractory only
-
Prior chemotherapy (unless allowed for some study arms)
-
Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
-
Prior use of any chronic systemic glucocorticoids .
-
Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
-
Prior treatment with Alpharadin® (Xofigo®)
-
Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
-
Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
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Severe systemic diseases or active uncontrolled illnesses.
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Abnormal heart function
-
Liver metastases
-
Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
-
The patient has known allergy to any of the treatment components
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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
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History of excessive alcohol consumption
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Use of any substance known to cause AME
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose Expansion galeterone Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension Dose Confirmation galeterone Dose A - galeterone tablets once daily PO for three months + extension Dose B - galeterone tablets once daily PO for three months + extension Dose C - galeterone tablets once daily PO for three months + extension
- Primary Outcome Measures
Name Time Method Confirmation of recommended dose and patient population for Part 2 of the study. 3 months Confirmation of recommended dose and patient population for Part 2 of the study.
Assessment of efficacy by means of PSA response. 3 months Assessment of efficacy by means of PSA response.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
UCLA David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
AAHS Research Institute
🇺🇸Annapolis, Maryland, United States
Tulane Cancer Center
🇺🇸New Orleans, Louisiana, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Mount Sinai
🇺🇸New York, New York, United States
Sidney Kimmel Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Urology Cancer Center and GU Research Network
🇺🇸Omaha, Nebraska, United States
Premier Urology Associates, LLC
🇺🇸Lawrenceville, New Jersey, United States
Urology Clinics of North Texas
🇺🇸Dallas, Texas, United States
Carolina Urologic Research Center
🇺🇸Myrtle Beach, South Carolina, United States
San Bernardino Urological Associates
🇺🇸San Bernardino, California, United States
Raton Regional Hospital, Lynn Cancer Institute
🇺🇸Boca Raton, Florida, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Coastal Urology Associates
🇺🇸Brick, New Jersey, United States
Roswell Park Center Institute
🇺🇸Buffalo, New York, United States
Carolina Clinical Trials
🇺🇸Concord, North Carolina, United States
Greenville Hospital System University Medical Center
🇺🇸Greenville, South Carolina, United States
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
University of Washington/Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States