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Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer

NCT01597193 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2019-05-08

Study results available
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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.

Conditions

Interventions

DRUG

enzalutamide

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

DRUG

anastrozole

1 mg/day

DRUG

exemestane

The exemestane dose is 25mg daily.

DRUG

fulvestrant

500 mg every 28 days

DRUG

enzalutamide

160 mg (4 capsules) taken orally daily.

DRUG

exemestane

The exemestane dose is 50 mg daily.

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-12-15
Completion
2018-01-22

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01597193 on ClinicalTrials.gov