non-small cell lung cancer
Conditions
Interventions
investigational material(s)
Generic name etc : PF-02341066
INN of investigational material : Crizotinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigati
Sponsors
Pfizer R&D Japan G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Patients with NSCLC harboring MET Exon 14 alterations * Solid tumors must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST v. 1.0). * All patients must provide a formalin-fixed paraffin-embedded (FFPE) archival tumor specimen, specifically a FFPE tissue block that contains sufficient tissue to generate at least 10 (preferably 15) unstained slides, each with tissue sections that are 5-10 microns thick. * Adequate blood cell counts, kidney function, liver function
Exclusion criteria
Exclusion criteria: * Major surgery, radiation therapy, or systemic anti-cancer therapy within 2 weeks of starting study treatment. * Brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease unless appropriately treated and neurologically stable for at least 2 weeks * Ongoing cardiac dysrhythmias of NCI CTCAE Grade >=2, uncontrolled atrial fibrillation of any grade, or QTc >470 msec. * Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy). * Pregnant female patients, breastfeeding female patients * Use of drugs that are known strong CYP3A4 inhibitors within 7 days prior to the first dose of PF-02341066 * Use of drugs that are known strong CYP3A4 inducers within 12 days prior to the first dose of PF-02341066 * Patients with known interstitial fibrosis or interstitial lung disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety pharmacokinetics * To determine the safety, tolerability of PF-02341066. * To characterize the plasma pharmacokinetic (PK) profile following oral administration of PF-02341066 * To document evidence of anti-tumor activity, including tumor response rate, duration of response, time to response, progression free survival, overall survival, probabilities of survival at 6 and 12 months and others as appropriate * Predictive or pharmacodynamics biomarkers in tumor and peripheral blood that may be relevant to the mechanism of action of, or the development of resistance to PF-02341066 (eg, plasma circulating nucleic acid). | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacodynamics pharmacogenomics - | — |
Countries
Japan, North America
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed