Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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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.
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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:
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Currently receiving crizotinib, another ALK inhibitor, or an investigational product.
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Adult patients who have been previously treated with crizotinib.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Children's Hospital Colorado | Aurora | Colorado | United States | 80045 |
2 | Children's Healthcare of Atlanta | Atlanta | Georgia | United States | 30322 |
3 | Children's Healthcare of Atlanta | Atlanta | Georgia | United States | 30342 |
4 | Boston Children's Hospital | Boston | Massachusetts | United States | 02215 |
5 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
6 | West Chester Medical Center | Hawthorne | New York | United States | 10532 |
7 | Cohen Children's Medical Center | New Hyde Park | New York | United States | 11040 |
8 | New York Medical College | Valhalla | New York | United States | 10595 |
9 | Westchester Medical Center/Maria Fareri Children's Hospital | Valhalla | New York | United States | 10595 |
10 | Children's Hospital of Philadelphia (CHOP) | Philadelphia | Pennsylvania | United States | 19104 |
11 | Children's Hospital of Philadelphia (Investigational Pharmacy) | Philadelphia | Pennsylvania | United States | 19104 |
12 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
13 | St. Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
14 | Children's Hospital of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
15 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- A8081056
- A8081056