CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 140 enrolled
Drug / intervention
MDV3100drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00510718
NCT00510718Phase 1Completed
CompareCT.gov

A PHASE 1, OPEN-LABEL, DOSE-ESCALATION SAFETY AND PHARMACOKINETIC STUDY OF MDV3100 IN PATIENTS WITH CASTRATION-RESISTANT PROSTATE CANCER

Pfizer·interventional·Posted Aug 2, 2007·Updated Oct 3, 2019

In Brief

A Phase 1 clinical trial evaluating MDV3100 for Prostate Cancer and Hormone Refractory Prostate Cancer. Completed, enrolled 140 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer, Hormone Refractory Prostate Cancer
CountriesUnited States
CollaboratorsAstellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2, 2007
Enrollment StartJul 23, 2007
Primary CompletionDec 8, 2008
Study CompletionApr 2, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.9 years ago

Interventions

MDV3100drug

MDV3100 daily until progression or dose-limiting toxicity