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Brief Title: A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue to Smoke After Failure of One or Two Prior Chemotherapy Regimens
Official Title: A Two-Stage Phase 1 Dose Escalation Pharmacokinetic Study of Tarceva® (Erlotinib) in Patients With Stage IIIB/IV Non-small Cell Lung Cancer Who Continue To Smoke After Failure of One or Two Prior Chemotherapy Regimens
Study ID: NCT00294736
Brief Summary: This is a multicenter, open-label, randomized phase 1 study of escalating doses of Tarceva in patients with advanced NSCLC who currently smoke. Part I will establish the maximum tolerated dose (MTD) of Tarceva in current smokers. In Part II, patients will be randomized 1:1 to two treatment groups: Arm A (Tarceva MTD established in Part I) and Arm B (150 mg Tarceva daily). Patients in both arms will be treated for two weeks and then have pharmacokinetic samples collected on day 14. Part II is open as of Nov-2006.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
University of Edinburgh,Division of Oncology,, Edinburgh, Scotland, United Kingdom
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
Ninewells Hospital, Dundee, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Sir Bobby Robson Cancer Trials Research Centre, Newcastle upon Tyne, , United Kingdom
Department of Oncology, Sheffield, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Name: Medical Monitor
Affiliation: OSI Pharmaceuticals
Role: STUDY_DIRECTOR