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

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer. Patients will first be enrolled into Phase 1 of the study to identify a tolerable dose for the Phase 2 portion of the study. In the Phase 2, 3 different cohorts of patients will be enrolled to evaluate the safety and activity of ARN-509.

Key facts

Study ID

NCT01171898

Run by

Aragon Pharmaceuticals, Inc.

People needed

127

Starts

2010-07-26

Expected to finish

2025-07-22

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
• Castrate levels of serum testosterone of less than or equal to 50 ng/dL
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• A life expectancy of at least 3 months

You may not qualify if…

• Distant metastases, including CNS and vertebral or meningeal involvement
• Prior treatment with MDV3100
• Prior treatment with abiraterone
• Prior treatment with ketoconazole
• Concurrent treatment with medications known to have seizure potential
• Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
• QTc > 450 msec
• History of seizure or condition that may predispose to seizure
• Evidence of severe or uncontrolled systemic disease or HIV infection
• METASTATIC CRPC, TREATMENT-NAIVE
• Inclusion Criteria
• Histologically or cytologically proven prostate cancer with progressive disease based on either PSA or radiographic progression
• Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration)
• Castrate levels of serum testosterone of less than or equal to 50 ng/dL
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• A life expectancy of at least 3 months
• Exclusion Criteria
• History of, or current metastases in the brain or untreated spinal cord compression
• Prior treatment with MDV3100
• Prior treatment with abiraterone
• Prior treatment with ketoconazole
• Concurrent treatment with medications known to have seizure potential
• Concurrent treatment with corticosteroids. If they are already on steroids, patients will be allowed to enroll on the study but will need to taper off as soon as possible.
• QTc > 450 msec
• History of seizure or condition that may predispose to seizure

Where it is running

• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — New York, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Portland, Oregon, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Myrtle Beach, South Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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