Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
An Open-Label, Phase 1/2, Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 in Patients With Progressive Advanced Castration-Resistant Prostate Cancer
Sponsor: Aragon Pharmaceuticals, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12
Time frame: Week 12
Secondary Endpoints
Phase 1 and 2: Median Time to PSA Progression
Phase 2: Median Metastasis-Free Survival (MFS)
Phase 1 and 2: Progression-free Survival (PFS)
Eligibility Criteria
NON-METASTATIC CRPC Inclusion Criteria 1. Histologically or cytologically proven prostate cancer with high risk for development of metastases, defined as either a PSA value \>=8 ng/mL within the last 3 months or PSA Doubling Time \<=10 months 2. Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration) 3. Castrate levels of serum testosterone of less than or equal to 50 ng/dL 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 5. A life expectancy of at least 3 months Exclusion Criteria 1. Distant metastases, including CNS and vertebral or meningeal involvement 2. Prior treatment with MDV3100 3. Prior treatment with abiraterone 4. Prior treatment with ketoconazole 5. Concurrent treatment with medications known to have seizure potential 6. Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but w…
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