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Results From an Expanded Cohort Phase 1 Study Published in the New England Journal of Medicine Demonstrate a Majority of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer Responded to Crizotinib (PF-02341066)
Date:10/27/2010

ormation on these clinical trials, please contact the Pfizer Oncology Clinical Trial Information Service at 1-877-369-9753 (US/Canada) or 1-646-277-4066 (international), via email at PfizerHPTrials@emergingmed.com or visit www.pfizercancertrials.com.

Study Results Published in the New England Journal of Medicine

In the Part 2 expansion cohort study which included 82 patients with ALK-positive advanced NSCLC, 57 percent (n=47)(95% CI 46%, 68%) of patients treated with crizotinib (PF-02341066) at a dose of 250 mg twice daily had either a complete or partial response to treatment.  An additional 33 percent (n=27) met criteria for stable disease, including five unconfirmed partial responses.  At eight weeks, the disease control rate (complete response (n=1) + partial response (n=46) + stable disease (n=24)) was 87 percent (n=71).  Three patients with stable disease were not included in the disease control rate because their evaluation for response was outside a pre-specified timeframe.(1)

At the time of the analysis, 77 percent of patients (n=63) continued to receive treatment with crizotinib (PF-02341066).  The median duration of treatment was 6.4 months, and follow-up is ongoing.  

The most commonly reported all-grade adverse events associated with crizotinib included nausea (n=44), diarrhea (n=39), vomiting (n=36), and mild visual disturbances (n=34).  Grade 3 ALT (alanine aminotransferase) and AST (aspartate aminotransferase) elevations occurred in four patients.  One patient experienced a Grade 4 elevation in ALT and one patient discontinued treatment due to Grade 3 ALT increases. Tumors in the analysis were primarily of adenocarcinoma histology, and patients tended to be young, and were never or former light smokers.  Ninety-three percent of patients (n=76)
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