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

NCT ID: NCT01709734

Last Updated: 2023-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2016-09-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Confirmation

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

Group Type: EXPERIMENTAL

galeterone

Intervention Type: DRUG

Dose Expansion

Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension

Group Type: EXPERIMENTAL

galeterone

Intervention Type: DRUG

Interventions

galeterone

Intervention Type: DRUG

Other Intervention Names

TOK-001

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

LTN PHARMACEUTICALS, INC.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Montgomery, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington Seattle Cancer Care Alliance

Mary Ellen Taplin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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

Countries

United States; Canada

Other Identifiers

TOK-200-10

Identifier Type: -

Identifier Source: org_study_id