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Hepatic Impairment Study For Crizotinib In Advanced Cancer Patients

NCT01576406 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-10-25

Study results available
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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

Interventions

DRUG

crizotinib

crizotinib 250 mg twice a day

DRUG

crizotinib

crizotinib 250 mg once a day

DRUG

crizotinib

crizotinib 250 mg twice a day

DRUG

crizotinib

crizotinib 250 mg once a day

DRUG

crizotinib

crizotinib 250 mg once a day

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-06-30
Completion
2016-06-30

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 NCT01576406 on ClinicalTrials.gov