Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients
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
1 other identifier
expanded_access
N/A
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
17 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedJune 26, 2024
June 1, 2024
June 12, 2015
June 24, 2024
Conditions
Keywords
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (17)
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
West Chester Medical Center
Hawthorne, New York, 10532, United States
Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
New York Medical College
Valhalla, New York, 10595, United States
Westchester Medical Center/Maria Fareri Children's Hospital
Valhalla, New York, 10595, United States
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of Philadelphia (Investigational Pharmacy)
Philadelphia, Pennsylvania, 19104, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 16, 2015
Last Updated
June 26, 2024
Record last verified: 2024-06