NCT00510718

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Pfizer · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostate Cancer
• Hormone Refractory Prostate Cancer

Interventions

Type	Name	Description
DRUG	MDV3100	MDV3100 daily until progression or dose-limiting toxicity

Timeline

• Start date: 2007-07-23
• Primary completion: 2008-12-08
• Completion: 2018-04-02
• First posted: 2007-08-02
• Last updated: 2019-10-03
• Results posted: 2019-10-03

Locations

9 sites across 1 country: United States