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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00510718
Recruitment Status : Active, not recruiting
First Posted : August 2, 2007
Last Update Posted : December 14, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Hormone Refractory Prostate Cancer Drug: MDV3100 Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Masking: None (Open Label)
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
Actual Study Start Date : July 2007
Primary Completion Date : December 2008
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Drug: MDV3100
MDV3100 daily until progression or dose-limiting toxicity
Other Names:
  • enzalutamide
  • Xtandi

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510718

United States, Massachusetts
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
MSKCC- Sidney Kimmel Center
New York, New York, United States, 10065
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
Investigational Pharmacy Services
Houston, Texas, United States, 77030-4009
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00510718     History of Changes
Obsolete Identifiers: NCT00513812
Other Study ID Numbers: S-3100-1-01
C3431009 ( Other Identifier: Alias Study Number )
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases