CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 101 enrolled
Drug / intervention
enzalutamide +5 moredrug
Likely dose
enzalutamide 80 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/NCT01597193
NCT01597193Phase 1Completed
CompareCT.gov

A PHASE 1 OPEN-LABEL, DOSE ESCALATION STUDY EVALUATING THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF ENZALUTAMIDE (FORMERLY MDV3100) IN PATIENTS WITH INCURABLE BREAST CANCER

Pfizer·interventional·Posted May 11, 2012·Updated May 8, 2019

In Brief

A Phase 1 clinical trial evaluating enzalutamide, anastrozole, and 2 other interventions for Breast Cancer. Completed, enrolled 101 participants across 17 sites.

Detailed Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2012
Enrollment StartApr 30, 2012
Primary CompletionDec 15, 2015
Study CompletionJan 22, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 14.1 years ago

Interventions

enzalutamidedrug

80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.

anastrozoledrug

1 mg/day

exemestanedrug

The exemestane dose is 25mg daily.

fulvestrantdrug

500 mg every 28 days

enzalutamidedrug

160 mg (4 capsules) taken orally daily.

exemestanedrug

The exemestane dose is 50 mg daily.