Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of a primary or metastaticmalignancy that is positive for a chromosomal translocation or activating mutationinvolving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene, as determined by local clinical testing that is appropriately validated inaccordance with applicable regulatory guidelines and/or practice standards (patientswith tumors harbouring other genetic alterations that may potentially benefit fromtreatment with crizotinib eg NTRK3 ETV6 fusion gene may be considered on a case bycase basis subject to approval by the sponsor).

• Inability to swallow crizotinib capsules, adult patients of whom must either have afeeding tube in place or have completed clinical evaluation of dysphagia without anyreversible causes identified.

• At least 12 months of age (patients <12 months of age will be evaluated on a case bycase basis and discussed with the sponsor).

Exclusion Criteria:

• Currently receiving crizotinib, another ALK inhibitor, or an investigationalproduct.

• Adult patients who have been previously treated with crizotinib.