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

Completed · Phase 1

Conditions studied: Prostate Cancer, Hormone Refractory Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00510718

Run by

Pfizer

People needed

140

Starts

2007-07-23

Expected to finish

2018-04-02

Last updated by the study team

2019-10-03

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Dana-Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• MSKCC- Sidney Kimmel Center — New York, New York, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Investigational Pharmacy Services — Houston, Texas, United States
• The University of Texas M.D. Anderson Cancer Center — Houston, Texas, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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