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



Status:Available
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:3/7/2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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CRIZOTINIB (XALKORI(REGISTERED)) EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERATION BUT WHO ARE UNABLE TO SWALLOW CRIZOTINIB CAPSULES

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.

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.

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.
We found this trial at
13
sites
40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Memphis, TN
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Atlanta, GA
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Hawthorne, New York 10532
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Hawthorne, NY
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Milwaukee, WI
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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New Hyde Park, New York 11040
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3401 Civic Center Boulevard
Philadelphia, Pennsylvania 19104
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Valhalla, NY
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