This is a Phase Ib, open label study of ARN-509 administered in combination with abiraterone acetate and prednisone in patients with metastatic castration-resistant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Dose-escalation: 120 milligram (mg), 180 mg, 240 mg, oral, daily
1,000 mg, oral, daily
5 mg, oral, daily
Unnamed facility
Boston, Massachusetts, United States
Maximum Tolerated Dose (MTD) / Recommended Phase 2 dosage (RP2D)
To determine the Maximum Tolerated Dosage (MTD)/ Recommended Phase 2 dosage (RP2D) of ARN-509 when administered in combination with abiraterone acetate.
Time frame: 12 months
Pharmacokinetics
To characterize the pharmacokinetics (PK) of abiraterone at steady-state prior to ARN-509 administration, and both abiraterone and ARN-509 at steady-state following combined dosing of both agents.
Time frame: 12 months
Anti-tumor activity
To perform preliminary assessment of the anti-tumor activity of ARN 509 in combination with abiraterone acetate by evaluation of radiographic tumor response by modified RECIST criteria.
Time frame: 12 months
PSA Response
To assess the magnitude and duration of PSA response in patients receiving ARN 509 plus abiraterone acetate.
Time frame: 12 months
Treatment Response/Resistance
To analyze potential mechanisms of response and resistance to treatment with ARN-509 plus abiraterone acetate in tissue obtained from serial biopsies of CRPC.
Time frame: 12 months
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