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

Last updated on April 13, 2018

FOR MORE INFORMATION
Study Location
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, 02115 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer, Hormone Refractory Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00510718
Pfizer
Completed
A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer

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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
Masking: None (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
January 2018
December 2008   (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);

Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00510718
S-3100-1-01
C3431009 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
  • Astellas Pharma Inc
  • Medivation, Inc.
Study Director: Pfizer Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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