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

Sponsor
Pfizer (Industry)
Overall Status
Available
CT.gov ID
NCT02473497
Collaborator
(none)
15

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

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

Study Type:
Expanded Access
Official Title:
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02473497
    Other Study ID Numbers:
    • A8081056
    • A8081056
    First Posted:
    Jun 16, 2015
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022

    Study Results

    No Results Posted as of Jan 28, 2022