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NCT01597193 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer, sponsored by Pfizer.

Completed
Registry status
Phase 1
Development phase
101
Enrollment target
17
Study locations

NCT01597193 is a Phase 1 study of Breast Cancer that has completed, run by Pfizer. The registered enrollment target is 101 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 17 study locations across 7 states.

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The verdict

NCT01597193, a Phase 1 study of Breast Cancer, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
101 participants
Enrollment target
17
Study locations

Study 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 Studied

Breast Cancer

Interventions

  • DRUG enzalutamide
  • DRUG fulvestrant
  • DRUG anastrozole
  • DRUG exemestane

Study Locations (17)

Tennessee

  • The West Clinic - Germantown
  • The West Clinic - Memphis
  • The West Clinic - Memphis
  • Tennessee Oncology, PLLC. - Nashville
  • The Sarah Cannon Research Institute - Nashville

New York

  • Memorial Sloan Kettering Cancer Center - New York
  • Memorial Sloan Kettering Cancer Center - IDS Pharmacy - New York
  • Memorial Sloan Kettering Cancer Center - OPD Pharmacy - New York
  • Memorial Sloan Kettering Cancer Center - New York

Colorado

  • ATTN-Research Pharmacist - Aurora
  • University of Colorado Cancer Center - Aurora
  • University of Colorado Hospital, Anschutz Outpatient Pavilion - Aurora

Mississippi

  • The West Clinic, PC - Corinth
  • The West Clinic - Southaven

Connecticut

  • Connecticut Multispecialty Group - Enfield

Florida

  • Florida Cancer Specialists - Sarasota

Michigan

  • Karmanos Cancer Institute - Detroit

Trial Details

FieldValue
Enrollment Target 101 participants
Start Date 2012-04-30
Est. Completion 2018-01-22
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

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What the Registry Record Tells You About NCT01597193

The ClinicalTrials.gov registry entry for NCT01597193 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which enzalutamide is the first listed.

NCT01597193 reports 17 study locations spanning 7 distinct geographic areas - top geographies include Tennessee, New York, Colorado.

Frequently Asked Questions

What is clinical trial NCT01597193 about?

NCT01597193 is a clinical study titled "Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer". 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.

What is the current status of trial NCT01597193?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 101 participants. The study started on 2012-04-30. Estimated completion is 2018-01-22.

What conditions does trial NCT01597193 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT01597193?

The interventions under investigation include: enzalutamide (DRUG), fulvestrant (DRUG), anastrozole (DRUG), exemestane (DRUG).

Who is sponsoring clinical trial NCT01597193?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01597193 being conducted?

This trial has 17 study locations across Colorado, Connecticut, Florida, Michigan, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.