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NCT00965731 · ClinicalTrials.gov registry record · Phase 1
Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 16
- Study locations
NCT00965731: Completed Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Pfizer.
NCT00965731 is a Phase 1 study of Non-Small Cell Lung Cancer that has completed, run by Pfizer. The registered enrollment target is 27 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower). The trial reports 16 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00965731, a Phase 1 study of Non-Small Cell Lung Cancer, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 16
- Study locations
Study Summary
This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.
Primary Outcome
Phase 1, first cycle DLT includes Grade (Gr) ≥4 hematologic possible drug-related toxicities and Gr ≥3 possible drug-related febrile neutropenia. Gr ≥3 non-hematological possible drug-related toxicities (except asymptomatic lab value elevation). Gr 3/4 nausea, vomiting or diarrhea. Gr 3 hypertension considered DLT if event unmanageable by approved pharmacologic agents or symptomatic sequelae despite medical intervention. Diagnosis of interstitial lung disease. Inability to deliver at least 80 pe
Conditions Studied
Interventions
- DRUG Erlotinib
- DRUG PF-02341066
Study Locations (16)
Missouri
- Siteman Cancer Center - City of Saint Peters
- Siteman Cancer Center -West County - Creve Coeur
- Barnes-Jewish Hospital - St Louis
- Washington University, School of Medicine - St Louis
California
- University of California, Irvine Medical Center Pharmacy - Orange
- University of California, Irving - Medical Center - Orange
- University of California Irvin - Orange
Ohio
- OSU East - Columbus
- The Ohio State University James Cancer Hospital - Columbus
- James Care in Kenny - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
- University of Alabama at Birmingham - Birmingham
Washington
- Seattle Cancer Care Alliance - Seattle
- University of Washington Medical Center - Seattle
Florida
- Holy Cross Hospital - Fort Lauderdale
Texas
- Cancer Therapy & Research Center @ UTHSCSA - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT00965731 record still lists
NCT00965731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Erlotinib is the first listed.
NCT00965731 lists 16 locations in 7 states (Missouri, California, Ohio).
Frequently Asked Questions
What is clinical trial NCT00965731 about?
NCT00965731 is a clinical study titled "Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer". This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.
What is the current status of trial NCT00965731?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-01. Estimated completion is 2014-01.
What conditions does trial NCT00965731 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT00965731?
The interventions under investigation include: Erlotinib (DRUG), PF-02341066 (DRUG).
Who is sponsoring clinical trial NCT00965731?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00965731 being conducted?
This trial has 16 study locations across Alabama, California, Florida, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00965731's enrollment target sits among peer trials
27 401st of 454 higher than 53 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung 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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