A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer (ARMOR2)

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

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

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: galeterone

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • BC Cancer Agency
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
• United States
  • California
    • Los Angeles, California, United States, 90095-7384
      • UCLA David Geffen School of Medicine
    • San Bernardino, California, United States, 92404
      • San Bernardino Urological Associates
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Raton Regional Hospital, Lynn Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Cancer Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • AAHS Research Institute
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Baltimore, Maryland, United States, 21205
      • Sidney Kimmel Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Urology Cancer Center and GU Research Network
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • Coastal Urology Associates
    • Lawrenceville, New Jersey, United States, 08648
      • Premier Urology Associates, LLC
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Center Institute
    • New York, New York, United States, 10029
      • Mount Sinai
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • Carolina Clinical Trials
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System University Medical Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urologic Research Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Urology Clinics of North Texas
  • Washington
    • Seattle, Washington, United States, 98136
      • University of Washington/Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: galeterone; Other Names: TOK-001
Experimental: Dose Expansion; Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension	Drug: galeterone; Other Names: TOK-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: LTN PHARMACEUTICALS, INC.
• Investigators: Principal Investigator: Bruce Montgomery, M.D., University of Washington Seattle Cancer Care Alliance; Principal Investigator: Mary Ellen Taplin, M.D., Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 16, 2012
• First Posted (Estimate): October 18, 2012

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: prostate cancer CRPC
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; 3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene
• Other Study ID Numbers: TOK-200-10