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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: Completed Phase 1 study of Advanced Cancer, sponsored by Pfizer.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Area under the plasma concentration-time curve from time zero to the quantifiable concentration at the end of dosing interval (tau hours post-dose, where tau was 12 hours for twice daily dosing and 24 hours for once daily dosing) of Cycle 2 Day 1.
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
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-06 |
| Phase | Phase 1 |
What the finished NCT01576406 record still lists
NCT01576406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (64% lower).
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 names 20 study sites across 5 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01576406's enrollment target sits among peer trials
88 63rd of 122 higher than 60 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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