A8081005 PF-02341066 in patients with advanced NSCLC with the ALK gene
Research type
Research Study
Full title
PHASE 2, OPEN-LABEL SINGLE ARM STUDY OF THE EFFICACY AND SAFETY OF PF 02341066 IN PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) HARBORING A TRANSLOCATION OR INVERSION INVOLVING THE ANAPLASTIC LYMPHOMA KINASE (ALK) GENE LOCUS
IRAS ID
35877
Contact name
Fiona Blackhall
Sponsor organisation
Pfizer Inc 235 East 42nd Street, New York, NY10017
Eudract number
2009-012504-13
Clinicaltrials.gov Identifier
Research summary
A8081005 is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This specific genetic profile is relatively rare, occurring in approximately 5-7% of patients with NSCLC. PF-02341066 is a new investigational oral anti-cancer drug made by Pfizer which inhibits the tumour activity of the ALK gene fusion. Early patient data suggests that PF-02341066 may slow cancer growth in this group of patients.A8081005 will provide the following patients the opportunity to receive PF02341066 in a clinical trial setting:1) Patients who are ineligible for the Phase 3 study (A8081007 standard chemotherapy versus PF02341066) due to previous treatment regimens.2) Patients who have entered the Phase 3 study but whose tumours have progressed whilst receiving standard chemotherapy.The purpose of this study is to see whether this new agent, PF-02341066, can suppress tumour growth, to examine the safety and side effects of PF-02341066, to measure how much PF-02341066 is in your blood and measure quality of life (QOL) while taking PF-02341066Patients will take PF-02341066 in tablet form twice daily. Patients will receive study treatment for as long as they continue to benefit from the treatment.The study is being sponsored by Pfizer, and will include a total of 200 patients across a number of countries; Argentina, Australia, Brazil, Bulgaria, Canada, China, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Korea, Netherlands, Poland, Romania, Russia, Spain, Sweden, UK and US. Patients will undergo a number of trial related assessments including blood tests, tumour assessments, physical examinations, QOL questionnaires, ECGs, ophthalmological assessments, and will be followed up for survival for up to 18 months following completion of the study treatment.
REC name
North West - Haydock Research Ethics Committee
REC reference
09/H1010/76
Date of REC Opinion
20 Jan 2010
REC opinion
Further Information Favourable Opinion