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NCT01576406 · ClinicalTrials.gov registry record · Phase 1

Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients

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

Completed
Registry status
Phase 1
Development phase
88
Enrollment target
20
Study locations

NCT01576406 is a Phase 1 study of Advanced Cancer that has completed, run by Pfizer. The registered enrollment target is 88 participants, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT01576406, a Phase 1 study of Advanced Cancer, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 1
Development phase
88 participants
Enrollment target
20
Study locations

Study Summary

This study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetics and safety of crizotinib in advanced cancer patients. Advanced cancer patients with mild, moderate or severe liver dysfunction as well as patients with normal liver function will be enrolled in this study.

Conditions Studied

Interventions

  • DRUG crizotinib

Study Locations (20)

Georgia

  • Emory University Hospital Midtown Laboratory - Atlanta
  • Emory University Hospital - Atlanta
  • Investigational Drug Service: The Emory Clinic Bldg A - Atlanta
  • The Emory Clinic - Atlanta
  • Winship Cancer Institute - Atlanta

Ohio

  • University Hospital East - Columbus
  • Investigational Drug Services - Columbus
  • James Cancer Hospital - Columbus
  • The Ohio State University, Wexner Medical Center - Columbus
  • Martha Morehouse Medical Plaza - Columbus

California

  • Keck Hospital of USC - Los Angeles
  • LAC&USC Medical Center - Los Angeles
  • USC/Norris Comprehensive Cancer Center / Investigational Drug Services - Los Angeles
  • USC/Norris Comprehensive Cancer Center - Los Angeles

Colorado

  • Anschutz Cancer Pavilion, Room 2224, c/o Melinda Friesleben, Pharm D - Aurora
  • University of Colorado Denver - Clinical Translational Research Center - Aurora
  • University of Colorado Denver, Anschutz Cancer Pavilion - Aurora
  • University of Colorado Denver, Anschutz Inpatient Pavillion - Aurora

Texas

  • Cancer Therapy & Research Center at UTHSCSA - San Antonio
  • Medical Arts and Research Center-MARC - San Antonio

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2012-07
Est. Completion 2016-06
Phase Phase 1

Sponsor

Pfizer

1,845 total trials

What the Registry Record Tells You About NCT01576406

The ClinicalTrials.gov registry entry for NCT01576406 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (64% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Cancer appearing as the primary indexed condition, and to 1 intervention - of which crizotinib is the first listed.

NCT01576406 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Georgia, Ohio, California.

Frequently Asked Questions

What is clinical trial NCT01576406 about?

NCT01576406 is a clinical study titled "Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients". This study is designed to evaluate the potential effect of hepatic impairment on the pharmacokinetics and safety of crizotinib in advanced cancer patients. Advanced cancer patients with mild, moderate or severe liver dysfunction as well as patients with normal liver function will be enrolled in this...

What is the current status of trial NCT01576406?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2012-07. Estimated completion is 2016-06.

What conditions does trial NCT01576406 study?

This clinical trial studies the following conditions: Advanced Cancer.

What interventions are being tested in trial NCT01576406?

The interventions under investigation include: crizotinib (DRUG).

Who is sponsoring clinical trial NCT01576406?

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

Where is trial NCT01576406 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Ohio, Texas. 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 Editorial

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.