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

This study is currently recruiting participants.
Verified March 2014 by Tokai Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Tokai Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01709734
First received: October 16, 2012
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: galeterone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Tokai Pharmaceuticals:

Primary Outcome Measures:
  • Confirmation of recommended dose and patient population for Part 2 of the study. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Assessment of efficacy by means of PSA response. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: December 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: TOK-001
Experimental: Dose Expansion
Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension
Drug: galeterone
Other Name: TOK-001

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709734

  Show 24 Study Locations
Sponsors and Collaborators
Tokai Pharmaceuticals
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
  More Information

No publications provided

Responsible Party: Tokai Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01709734     History of Changes
Other Study ID Numbers: TOK-200-10
Study First Received: October 16, 2012
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Tokai Pharmaceuticals:
prostate cancer CRPC

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014