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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.
Sponsor:
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00510718
First received: July 31, 2007
Last updated: August 25, 2016
Last verified: August 2016

July 31, 2007
August 25, 2016
July 2007
September 2010   (final data collection date for primary outcome measure)
Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Safety and Tolerability
Complete list of historical versions of study NCT00510718 on ClinicalTrials.gov Archive Site
Pharmacokinetics, PSA response [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Pharmacokinetics, PSA response
Not Provided
Not Provided
 
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer
A Phase 1, Open-Label, Dose-Escalation Safety and Pharmacokinetic Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer
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.
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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Prostate Cancer
  • Hormone Refractory Prostate Cancer
Drug: MDV3100
MDV3100 daily until progression or dose-limiting toxicity
Other Names:
  • enzalutamide
  • Xtandi
Experimental: 1
MDV3100
Intervention: Drug: MDV3100

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
December 2017
September 2010   (final data collection date for primary outcome measure)

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);

Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00510718
S-3100-1-01
No
Not Provided
Not Provided
Medivation, Inc.
Medivation, Inc.
Not Provided
Study Director: Medical Director Medivation, Inc.
Medivation, Inc.
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP