CompletedPhase 1/2

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

United States127 participantsStarted 2010-07-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Phase 1 and 2: Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in Prostate-Specific Antigen (PSA) at Week 12

Timeframe: Week 12

Trial details

NCT IDNCT01171898

SponsorAragon Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08-20

Results submitted2018-05-08

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