This is an open label expanded access protocol for the treatment of up to approximately40 adult or pediatric (defined as age
Crizotinib is indicated in the U.S. for the treatment of patients with metastatic
non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase
(ALK)-positive as detected by an FDA-approved test. Commercially available dosage forms
are 250 mg and 200 mg capsules. This expanded access protocol (EAP) is designed to
provide access to an alternative oral formulation of crizotinib for those patients who
are unable to swallow capsules.
Drug: Crizotinib
For adult patients, crizotinib 250 mg BID will be administered orally at approximately
the same time each day on a continuous daily dosing schedule, ie, without break in
dosing. For pediatric patients, crizotinib 280 mg/m2 BID will be administered orally at
approximately the same time each day on a continuous daily dosing schedule, ie, without
break in dosing.
Other Name: XALKORI
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.
Children's Hospital Colorado
Aurora, Colorado, United States
Johns Hopkins All Children's Hospital
Saint 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
Pfizer CT.gov Call Center, Study Director
Pfizer