Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

Pfizer

Status

Conditions: Neoplasms; Carcinoma, Non-Small-Cell Lung

Treatments: Drug: crizotinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT02824094

A8081064

Details and patient eligibility

About

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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