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Prostate Cancer Clinical Trials

Galeterone for Castration Resistant Prostate Cancer (ARMOR2)
ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
Status Conditions Phase Study ID
Recruiting Prostate Cancer Phase II NCT01709734
Summary

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.


Investigator
Robert Bruce Montgomery, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  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
Exclusions (conditions that would prevent participation in this study)
  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
Last Updated
September 16, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.