Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02473497 |
Expanded Access Status :
Available
First Posted : June 16, 2015
Last Update Posted : January 28, 2022
|
- Study Details
- Tabular View
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Neoplasm | Drug: Crizotinib |
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 |

- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
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.

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
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
United States, Colorado | |
Children's Hospital Colorado | Available |
Aurora, Colorado, United States, 80045 | |
United States, Georgia | |
Children's Healthcare of Atlanta | Available |
Atlanta, Georgia, United States, 30322 | |
Children's Healthcare of Atlanta | Available |
Atlanta, Georgia, United States, 30342 | |
United States, Massachusetts | |
Boston Children's Hospital | Available |
Boston, Massachusetts, United States, 02215 | |
Dana-Farber Cancer Institute | Available |
Boston, Massachusetts, United States, 02215 | |
United States, New York | |
West Chester Medical Center | Available |
Hawthorne, New York, United States, 10532 | |
Cohen Children's Medical Center | Available |
New Hyde Park, New York, United States, 11040 | |
New York Medical College | Available |
Valhalla, New York, United States, 10595 | |
Westchester Medical Center/Maria Fareri Children's Hospital | Available |
Valhalla, New York, United States, 10595 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia (CHOP) | Available |
Philadelphia, Pennsylvania, United States, 19104 | |
Children's Hospital of Philadelphia (Investigational Pharmacy) | Available |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Rhode Island | |
Rhode Island Hospital | Available |
Providence, Rhode Island, United States, 02903 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | Available |
Memphis, Tennessee, United States, 38105 | |
United States, Wisconsin | |
Children's Hospital of Wisconsin | Available |
Milwaukee, Wisconsin, United States, 53226 | |
Medical College of Wisconsin | Available |
Milwaukee, Wisconsin, United States, 53226 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT02473497 |
Other Study ID Numbers: |
A8081056 A8081056 ( Other Identifier: Alias Study Number ) |
First Posted: | June 16, 2015 Key Record Dates |
Last Update Posted: | January 28, 2022 |
Last Verified: | January 2022 |
chromosomal rearrangement activating mutation activating genetic alteration genetic aberration ALK |
ROS1 cMET crizotinib oral formulation |
Crizotinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |