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

No Longer AvailableN/A

Sponsor: Pfizer

Conditions: Neoplasm

Interventions: Crizotinib

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 0 Years to —

Healthy volunteers: No

Study type: EXPANDED_ACCESS

Eligibility 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.

Locations (17)

Aurora, Colorado, United States
St. Petersburg, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Hawthorne, New York, United States
New Hyde Park, New York, United States
Valhalla, New York, United States
Valhalla, New York, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Milwaukee, Wisconsin, United States
Milwaukee, Wisconsin, United States