Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
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

October 16, 2012
March 27, 2014
December 2012
June 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Part 1 will confirm dose to be used in Part B of the study by assessing safety and efficacy by means PSA response. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    This study will monitor frequency and severity of adverse events and changes in laboratory values. This study will also assess changes in levels of prostate specific antigen as a measure of treatment response
  • Part 2 of this study will further assess efficacy of the dose of galeterone chosen in Part 1 of the study in terms of changes from baseline in PSA concentration and tumor response rate by RECIST criteria (v.1.1) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    RECIST will be evaluated by tumor changes measurements as seen on CT/MRI.
Complete list of historical versions of study NCT01709734 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: galeterone
Other Name: TOK-001
  • 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

    Intervention: Drug: galeterone
  • Experimental: Dose Expansion
    Single dose expansion (from part 1) of galeterone tablets once daily PO for three months + extension
    Intervention: Drug: galeterone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
144
September 2014
June 2014   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
United States,   Canada
 
NCT01709734
TOK-200-10
Yes
Tokai Pharmaceuticals
Tokai Pharmaceuticals
Not Provided
Principal Investigator: Bruce Montgomery, M.D. University of Washington/Seattle Cancer Care Alliance
Principal Investigator: Mary Ellen Taplin, M.D. Dana-Farber Cancer Institute
Tokai Pharmaceuticals
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP