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

STATUS: Recruiting

Phase:

Diagnosis: Pediatric Solid Tumors, Pediatric Leukemia

NCT ID: NCT02473497 (View complete trial on ClinicalTrials.gov)

DFCI Protocol ID: 16-555

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.

Conducting Institutions:

Children's Hospital Boston, Dana-Farber Cancer Institute


Overall PI:

Suzanne Shusterman, MD, Dana-Farber Cancer Institute


Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, , ctip@partners.org

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.

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