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)

Titre officiel

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

Sommaire:

Il s’agit d’un essai de phase I visant à évaluer l’innocuité et l’efficacité du crizotinib chez des patients porteurs de tumeurs, à l’exception du cancer du poumon non à petites cellules ALK-positif.

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov