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

• ClinicalTrials.gov Identifier: NCT02473497
• Expanded Access Status: Available
• First Posted: June 16, 2015
• Last Update Posted: September 20, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

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
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 Design

• 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

Interventions

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

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

Locations

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 (Investigational Pharmacy); Available

Philadelphia, Pennsylvania, United States, 19104

Children's Hospital of Philadelphia; 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, Texas

Texas Children's Hospital; Available

Houston, Texas, United States, 77030

United States, Wisconsin

Children's Hospital of Wisconsin; Available

Milwaukee, Wisconsin, United States, 53226

Medical College of Wisconsin; Available

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02473497
• Other Study ID Numbers: A8081056; A8081056 ( Other Identifier: Alias Study Number )
• First Posted: June 16, 2015
• Last Update Posted: September 20, 2019
• Last Verified: September 2019

Keywords provided by Pfizer:

chromosomal rearrangement; activating mutation; activating genetic alteration; genetic aberration; ALK; ROS1; cMET; crizotinib; oral formulation

Additional relevant MeSH terms:

Crizotinib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action