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

Information source: Tokai Pharmaceuticals
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: galeterone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Tokai Pharmaceuticals

Official(s) and/or principal investigator(s):
Bruce Montgomery, M.D., Principal Investigator, Affiliation: University of Washington/Seattle Cancer Care Alliance
Mary Ellen Taplin, M.D., Principal Investigator, Affiliation: Dana-Farber Cancer Institute

Summary

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

Clinical Details

Official title: ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Confirmation of recommended dose and patient population for Part 2 of the study.

Assessment of efficacy by means of PSA response.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the prostate 2. Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL 3. Demonstration of progression while on androgen blockade 4. Eastern Cooperative Oncology Group (ECOG) Performance Status <2 Exclusion Criteria: 1. 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

2. Prior chemotherapy (unless allowed for some study arms) 3. Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment 4. Prior use of any chronic systemic glucocorticoids . 5. Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment 6. Prior treatment with Alpharadin® (Xofigo®) 7. Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment 8. Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment 9. Severe systemic diseases or active uncontrolled illnesses. 10. Abnormal heart function 11. Liver metastases 12. Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy) 13. The patient has known allergy to any of the treatment components 14. 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 15. History of excessive alcohol consumption 16. Use of any substance known to cause AME

Locations and Contacts

BC Cancer Agency, Vancouver, British Columbia V5Z 4E6, Canada

UCLA David Geffen School of Medicine, Los Angeles, California 90095-7384, United States

San Bernardino Urological Associates, San Bernardino, California 92404, United States

Raton Regional Hospital, Lynn Cancer Institute, Boca Raton, Florida 33486, United States

Tulane Cancer Center, New Orleans, Louisiana 70112, United States

AAHS Research Institute, Annapolis, Maryland 21401, United States

Sidney Kimmel Johns Hopkins, Baltimore, Maryland 21205, United States

University of Maryland, Baltimore, Maryland 21201, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States

Dana Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Karmanos Cancer Institute, Detroit, Michigan 48201, United States

Urology Cancer Center and GU Research Network, Omaha, Nebraska 68130, United States

Coastal Urology Associates, Brick, New Jersey 08724, United States

Premier Urology Associates, LLC, Lawrenceville, New Jersey 08648, United States

Roswell Park Center Institute, Buffalo, New York 14263, United States

Mount Sinai, New York, New York 10029, United States

Carolina Clinical Trials, Concord, North Carolina 28025, United States

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada

Greenville Hospital System University Medical Center, Greenville, South Carolina 29605, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina 29572, United States

Texas Urology, Carollton, Texas 75234, United States

Urology Clinics of North Texas, Dallas, Texas 75230, United States

University of Washington/Seattle Cancer Care Alliance, Seattle, Washington 98136, United States

Additional Information

Starting date: December 2012
Last updated: March 19, 2015

Page last updated: August 20, 2015

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