Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

Crizotinib (Xalkori (Registered)) Expanded Access Protocol For The Treatment Of Japanese Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Ros1 Oncogene

Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
• Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.
• ECOG performance status 0 to 2.
• Adequate organ function
• Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.
• Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of crizotinib.

Exclusion Criteria:

• Currently receiving crizotinib or any investigational products.
• Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
• Carcinomatous meningitis or leptomeningeal disease.
• Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
• Ongoing uncontrolled congestive heart failure (CHF) and any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
• Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QTc more than 480 msec.
• History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
• Pregnant female patients; breastfeeding female patients.
• Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4 inducers and CYP3A4 substrates with narrow therapeutic indices