Journal article
Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: Updated results from a phase 1 study
DR Camidge, YJ Bang, EL Kwak, AJ Iafrate, M Varella-Garcia, SB Fox, GJ Riely, B Solomon, SHI Ou, DW Kim, R Salgia, P Fidias, JA Engelman, L Gandhi, PA Jänne, DB Costa, GI Shapiro, P LoRusso, K Ruffner, P Stephenson Show all
Lancet Oncology | Published : 2012
Abstract
Background: ALK fusion genes occur in a subset of non-small-cell lung cancers (NSCLCs). We assessed the tolerability and activity of crizotinib in patients with NSCLC who were prospectively identified to have an ALK fusion within the first-in-man phase 1 crizotinib study. Methods: In this phase 1 study, patients with ALK-positive stage III or IV NSCLC received oral crizotinib 250 mg twice daily in 28-day cycles. Endpoints included tumour responses, duration of response, time to tumour response, progression-free survival (PFS), overall survival at 6 and 12 months, and determination of the safety and tolerability and characterisation of the plasma pharmacokinetic profile of crizotinib after or..
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Awarded by National Cancer Institute
Funding Acknowledgements
DRC, Y-JB, ELK, AJI, BS, S-HIO, D-WK, PAJ, DBC, PLR, and ATS received honoraria or consulting fees from Pfizer. ELK, GJR, BS, and JWC received research funding from Pfizer. AJI, MV-G, and GJR received honoraria or consulting fees from Abbott Molecular. GJR, LG, and ATS received honoraria or consulting fees from Chugai. GJR received research funding from Chugai, Boehringer Ingelheim, Bristol-Myers Squibb, GlaxoSmithKline, Infinity Pharmaceuticals, and Merck; and honoraria or consulting fees from Daiichi and Tragara. GJR and ATS received honoraria or consulting fees from Novartis and Ariad and research funding from Novartis. PF received honoraria or consulting fees from Genentech. DBC received honoraria or consulting fees from AstraZeneca and Roche. KR, YT, and KW are employees and stockholders of Pfizer. ATS received research funding from AstraZeneca. SBF, RS, JAE, GIS, and PS declare that they have no conflicts of interest. We thank all the participating patients, their families, and the network of investigators, research nurses, study coordinators, and operations staff. The phase 1 clinical trial was sponsored by Pfizer. Investigators were supported in part by the National Cancer Institute P50-CA090578 (PAJ, DBC), the American Society of Clinical Oncology Conquer Cancer Foundation (DBC), and by internal funds from the Massachusetts General Hospital Cancer Center and Pathology Department (ATS, AJI). Editorial assistance was provided by Martin Quinn at Acumed (Tytherington, UK) and was funded by Pfizer.