A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer
This trial is active, not recruiting.
|Start date||December 2012|
|End date||September 2016|
|Trial size||126 participants|
|Trial identifier||NCT01709734, TOK-200-10|
A Phase 2, 2 part trial to evaluate the safety and efficacy of galeterone in castration resistant prostate cancer (CRPC) patients.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
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|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Confirmation of recommended dose and patient population for Part 2 of the study.
time frame: 3 months
Assessment of efficacy by means of PSA response.
time frame: 3 months
Male participants at least 18 years old.
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Ongoing androgen blockade demonstrated by serum testosterone concentration of less than 50 ng/dL
- Demonstration of progression while on androgen blockade
- Eastern Cooperative Oncology Group (ECOG) Performance Status <2
- 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
- Prior chemotherapy (unless allowed for some study arms)
- Treatment with non-steroidal oral antiandrogens within 4 weeks of enrollment
- Prior use of any chronic systemic glucocorticoids .
- Prior radiation therapy within 3 weeks and radionuclide therapy within 8 weeks of enrollment
- Prior treatment with Alpharadin® (Xofigo®)
- Treatment with anti arrhythmia therapy for ventricular arrhythmia < 4 weeks prior to enrollment
- Treatment with Coumadin® or other anti-coagulant therapy (except aspirin) < 4 weeks prior to enrollment
- Severe systemic diseases or active uncontrolled illnesses.
- Abnormal heart function
- Liver metastases
- Brain metastases (unless stable disease >3 mos. by scan without additional CNS-directed therapy)
- The patient has known allergy to any of the treatment components
- 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
- History of excessive alcohol consumption
- Use of any substance known to cause AME
|Official title||ARMOR2: A 2 Part, Phase 2 Trial of Galeterone in the Treatment of Castration Resistant Prostate Cancer|
|Principal investigator||Bruce Montgomery, M.D.|
|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.|
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