At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 127 enrolled

Drug / intervention

flutamidedrug

Likely dose

flutamide 125 MGfrom 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/NCT00699907

NCT00699907Phase 2Completed

Compare CT.gov

A Prospective, Phase IIA Study of the Effect of Flutamide (125 MG/DAY) Taken for 6 Weeks on Expression of Potential Biomarkers of Flutamide Action in the Ovaries of Women at Increased Risk for Ovarian Cancer

University of Arizona·interventional·Posted Jun 18, 2008·Updated Jul 24, 2018

In Brief

A Phase 2 clinical trial evaluating flutamide for Ovarian Cancer. Completed, enrolled 127 participants across 1 site.

Detailed Summary

Studying samples of blood and tissue in the laboratory from patients with a high risk of developing ovarian cancer may help doctors identify and learn more about biomarkers related to cancer. We hypothesized that (i) preclinical biologic evidence exists for the role of androgens in ovarian cancer development and (ii) flutamide treatment of women at high risk for ovarian cancer may identify meaningful tissue biomarkers of androgen action and of ovarian cancer initiation. This phase II trial studied the effect of flutamide on biomarkers in blood and tissue samples from patients at high risk of ovarian cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOvarian Cancer

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2005

First PostedJun 2008

Primary CompletionNov 2012

Study CompletionNov 2014

TodayJul 2026

First PostedJun 18, 2008

Enrollment StartJan 1, 2005

Primary CompletionNov 1, 2012

Study CompletionNov 1, 2014

TodayJul 2, 2026

Enrollment to primary: 7.8 yearsPosted 18.0 years ago

Interventions

flutamidedrug

Patients receive oral flutamide (125 MG/DAY) once daily for 6 weeks in the absence of unacceptable toxicity.