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

• Status: Available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label expanded access protocol for the treatment of up to approximately 40 adult or pediatric (defined as age <18 years) patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the cMET gene who cannot swallow the crizotinib capsule but may be able to derive benefit from treatment with an alternative oral formulation of crizotinib.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Crizotinib

Criteria

Inclusion Criteria:

• Histologically or cytologically proven diagnosis of a primary or metastatic malignancy that is positive for a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the c MET gene, as determined by local clinical testing that is appropriately validated in accordance with applicable regulatory guidelines and/or practice standards (patients with tumors harbouring other genetic alterations that may potentially benefit from treatment with crizotinib eg NTRK3 ETV6 fusion gene may be considered on a case by case basis subject to approval by the sponsor).

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

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

Exclusion Criteria:

• Currently receiving crizotinib, another ALK inhibitor, or an investigational product.

• Adult patients who have been previously treated with crizotinib.