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

Last updated on March 14, 2019

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Study Location
Children's Hospital Colorado
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasm
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 case basis and discussed with the sponsor).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Currently receiving crizotinib, another ALK inhibitor, or an investigational product.

- Adult patients who have been previously treated with crizotinib.

NCT02473497
Pfizer
Available
Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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