Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
NCT ID: NCT00965731
Last Updated: 2015-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2010-01-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Erlotinib
Erlotinib
Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)
Erlotinib + PF-02341066
Erlotinib
For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2
PF-02341066
For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2
Interventions
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Erlotinib
Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)
Erlotinib
For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2
PF-02341066
For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2
Eligibility Criteria
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Inclusion Criteria
* evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
* tumors must have measurable disease as per RECIST
Exclusion Criteria
* prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, Irvine Medical Center Pharmacy
Orange, California, United States
University of California, Irving - Medical Center
Orange, California, United States
University of California Irvin
Orange, California, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Siteman Cancer Center
City of Saint Peters, Missouri, United States
Siteman Cancer Center -West County
Creve Coeur, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University, School of Medicine
St Louis, Missouri, United States
OSU East
Columbus, Ohio, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States
James Care in Kenny
Columbus, Ohio, United States
Cancer Therapy & Research Center @ UTHSCSA
San Antonio, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2009-012377-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8081002
Identifier Type: -
Identifier Source: org_study_id
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