An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumours, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

Official Title

Phase 1B Open-Label Study Of The Safety And Clinical Activity Of Crizotinib (PF-02341066) In Tumours With Genetic Events Involving The Anaplastic Lymphoma (ALK) Gene Locus

Summary:

This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumours except non-small cell lung cancer that are positive for ALK.

Trial Description

Primary Outcome:

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities
• Overall Response Rate

• Duration of Response
• Plasma concentrations of crizotinib
• Overall Survival
• Proportion of patients with each of the ALK genetic events
• Progression-Free Survival (PFS)
• Phosphorylation status of ALK in the tumour samples from surgery or biopsy pre and post treatment when available

View this trial on ClinicalTrials.gov