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

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ClinicalTrials.gov Identifier: NCT02473497
Expanded Access Status : Available
First Posted : June 16, 2015
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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
Neoplasm Drug: Crizotinib

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 Type : Expanded Access
Expanded Access Type : Individual Patients
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

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib


Intervention Details:
  • 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473497


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
West Chester Medical Center
Hawthorne, New York, United States, 10532
Cohen Children's Medical Center
New Hyde Park, New York, United States, 11040
New York Medical College
Valhalla, New York, United States, 10595
Westchester Medical Center/Maria Fareri Children's Hospital
Valhalla, New York, United States, 10595
United States, Pennsylvania
Children's Hospital of Philadelphia (Investigational Pharmacy)
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02473497     History of Changes
Other Study ID Numbers: A8081056
A8081056 ( Other Identifier: Alias Study Number )
First Posted: June 16, 2015    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Keywords provided by Pfizer:
chromosomal rearrangement
activating mutation
activating genetic alteration
genetic aberration
ALK
ROS1
cMET
crizotinib
oral formulation

Additional relevant MeSH terms:
Crizotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action