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

NCT01709734 | Terminated Phase 2 DMC

• 1 other identifier: TOK-200-10
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 23

Brief Summary

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

Conditions

Prostate Cancer

Keywords

prostate cancer CRPC

Outcome Measures

Primary Outcomes (2)

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

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

  3 months

• Assessment of efficacy by means of PSA response.

  Assessment of efficacy by means of PSA response.

  3 months

Study Arms (2)

Dose Confirmation

EXPERIMENTAL

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

Drug: galeterone

Dose Expansion

EXPERIMENTAL

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

Drug: galeterone

Interventions

galeterone DRUG

Also known as: TOK-001

Dose Confirmation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• LTN PHARMACEUTICALS, INC.: lead

Study Sites (23)

UCLA David Geffen School of Medicine

Los Angeles, California, 90095-7384, United States

Location

San Bernardino Urological Associates

San Bernardino, California, 92404, United States

Location

Raton Regional Hospital, Lynn Cancer Institute

Boca Raton, Florida, 33486, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

Location

AAHS Research Institute

Annapolis, Maryland, 21401, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Urology Cancer Center and GU Research Network

Omaha, Nebraska, 68130, United States

Location

Coastal Urology Associates

Brick, New Jersey, 08724, United States

Location

Premier Urology Associates, LLC

Lawrenceville, New Jersey, 08648, United States

Location

Roswell Park Center Institute

Buffalo, New York, 14263, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Carolina Clinical Trials

Concord, North Carolina, 28025, United States

Location

Greenville Hospital System University Medical Center

Greenville, South Carolina, 29605, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75230, United States

Location

University of Washington/Seattle Cancer Care Alliance

Seattle, Washington, 98136, United States

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bruce Montgomery, M.D.

  University of Washington Seattle Cancer Care Alliance

  PRINCIPAL INVESTIGATOR

• Mary Ellen Taplin, M.D.

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 18, 2012
• Study Start: December 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 15, 2023

Record last verified: 2018-08

Locations

CA (2); US (21)