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

NO_LONGER_AVAILABLE

Conditions studied: Neoplasm

In brief

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.

Key facts

Study ID

NCT02473497

Run by

Pfizer

Last updated by the study team

2024-06-26

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Currently receiving crizotinib, another ALK inhibitor, or an investigational product.
• Adult patients who have been previously treated with crizotinib.

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• West Chester Medical Center — Hawthorne, New York, United States
• Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• New York Medical College — Valhalla, New York, United States
• Westchester Medical Center/Maria Fareri Children's Hospital — Valhalla, New York, United States
• Children's Hospital of Philadelphia (CHOP) — Philadelphia, Pennsylvania, United States
• Children's Hospital of Philadelphia (Investigational Pharmacy) — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Children's Medical Center Dallas — Dallas, Texas, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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