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A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medivation, Inc. Identifier:
First received: July 31, 2007
Last updated: January 18, 2017
Last verified: January 2017
This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.

Condition Intervention Phase
Prostate Cancer
Hormone Refractory Prostate Cancer
Drug: MDV3100
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

Resource links provided by NLM:

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Pharmacokinetics, PSA response [ Time Frame: 3 months ]

Enrollment: 140
Study Start Date: July 2007
Estimated Study Completion Date: December 2017
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: MDV3100
MDV3100 daily until progression or dose-limiting toxicity
Other Names:
  • enzalutamide
  • Xtandi

Detailed Description:
This is a Phase 1, open-label, uncontrolled, dose-escalation study with dose-expansion at doses determined to be tolerated. Patients who tolerate the drug and do not progress will be allowed to continue treatment. The study endpoints are safety and tolerability and pharmacokinetics. PSA values will also be collected to look for PSA response.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate;
  2. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration);
  3. Progressive disease after medical or surgical castration,

Exclusion Criteria:

1. Metastases in the brain or active epidural disease. (Note: patients with treated epidural disease are allowed);

  Contacts and Locations
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Please refer to this study by its identifier: NCT00510718

United States, New York
Memorial Sloan-Kettering Cancer Center
New York City, New York, United States, 10021
United States, Washington
University of Washington
Seattle, Washington, United States, 98502
Sponsors and Collaborators
Medivation, Inc.
Study Director: Medical Director Medivation, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medivation, Inc. Identifier: NCT00510718     History of Changes
Obsolete Identifiers: NCT00513812
Other Study ID Numbers: S-3100-1-01
Study First Received: July 31, 2007
Last Updated: January 18, 2017

Keywords provided by Medivation, Inc.:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on May 22, 2017