Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

July 26, 2010

Primary Completion Date

August 20, 2012

Study Completion Date

July 22, 2025

Conditions
Prostate Cancer
Interventions
DRUG

ARN-509 (Phase 1)

ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily.

DRUG

ARN-509 (Phase 2)

ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.

Trial Locations (15)

Unknown

San Diego

San Francisco

Atlanta

Baltimore

Boston

Ann Arbor

Omaha

New York

Raleigh

Portland

Lancaster

Myrtle Beach

Dallas

Seattle

Madison

Sponsors
All Listed Sponsors
lead

Aragon Pharmaceuticals, Inc.

INDUSTRY