Neoplasms Malignant
Conditions
Interventions
investigational material(s)
Generic name etc : Crizotinib
INN of investigational material : crizotinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigatio
Sponsors
Pfizer R&D Japan G.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Histologically or cytologically proven diagnosis of advanced malignancy other than * NSCLC for whom no standard therapy is available * Positive for translocation or inversion event involving the ALK gene locus * Positive for ALK amplification events * Positive for ALK activating point mutations
Exclusion criteria
Exclusion criteria: * Mutations or amplification involving the cMet gene but not the ALK gene locus * Concurrent treatment on another therapeutic clinical trial * Prior therapy specifically directed against ALK
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety * 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics pharmacogenomics 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 tumor samples from surgery or biopsy pre and post treatment when available | — |
Countries
Asia except Japan, Japan, North America
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed