Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients
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| ClinicalTrials.gov Identifier: NCT02473497 |
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Expanded Access Status :
Available
First Posted : June 16, 2015
Last Update Posted : December 18, 2018
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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 |
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
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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:
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chromosomal rearrangement activating mutation activating genetic alteration genetic aberration ALK |
ROS1 cMET crizotinib oral formulation |
Additional relevant MeSH terms:
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Crizotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |