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

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ClinicalTrials.gov Identifier: NCT01709734
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE October 18, 2012
Last Update Posted Date August 3, 2018
Study Start Date  ICMJE December 2012
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Confirmation of recommended dose and patient population for Part 2 of the study. [ Time Frame: 3 months ]
    Confirmation of recommended dose and patient population for Part 2 of the study.
  • Assessment of efficacy by means of PSA response. [ Time Frame: 3 months ]
    Assessment of efficacy by means of PSA response.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2012)
  • 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 ]
    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 ]
    RECIST will be evaluated by tumor changes measurements as seen on CT/MRI.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
Official Title  ICMJE ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: galeterone
Other Name: TOK-001
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2016)
126
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2012)
172
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01709734
Other Study ID Numbers  ICMJE TOK-200-10
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novus Therapeutics, Inc
Study Sponsor  ICMJE Novus Therapeutics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce Montgomery, M.D. University of Washington Seattle Cancer Care Alliance
Principal Investigator: Mary Ellen Taplin, M.D. Dana-Farber Cancer Institute
PRS Account Novus Therapeutics, Inc
Verification Date August 2018

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