A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.

Key facts

Study ID

NCT01709734

Run by

LTN PHARMACEUTICALS, INC.

People needed

126

Starts

2012-12-01

Expected to finish

2016-09-01

Last updated by the study team

2023-03-15

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Severe systemic diseases or active uncontrolled illnesses.
• 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
• 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
• History of excessive alcohol consumption
• Use of any substance known to cause AME

Where it is running

• UCLA David Geffen School of Medicine — Los Angeles, California, United States
• San Bernardino Urological Associates — San Bernardino, California, United States
• Raton Regional Hospital, Lynn Cancer Institute — Boca Raton, Florida, United States
• Tulane Cancer Center — New Orleans, Louisiana, United States
• AAHS Research Institute — Annapolis, Maryland, United States
• University of Maryland — Baltimore, Maryland, United States
• Sidney Kimmel Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Urology Cancer Center and GU Research Network — Omaha, Nebraska, United States
• Coastal Urology Associates — Brick, New Jersey, United States
• Premier Urology Associates, LLC — Lawrenceville, New Jersey, United States
• Roswell Park Center Institute — Buffalo, New York, United States
• Mount Sinai — New York, New York, United States
• Carolina Clinical Trials — Concord, North Carolina, United States
• Greenville Hospital System University Medical Center — Greenville, South Carolina, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Urology Clinics of North Texas — Dallas, Texas, United States
• University of Washington/Seattle Cancer Care Alliance — Seattle, Washington, United States
• BC Cancer Agency — Vancouver, British Columbia, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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