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

NCT ID: NCT02473497

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

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.

Conditions

Neoplasm

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

XALKORI

Eligibility 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.

• Minimum Eligible Age: 0 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

West Chester Medical Center

Hawthorne, New York, United States

Cohen Children's Medical Center of New York

New Hyde Park, New York, United States

New York Medical College

Valhalla, New York, United States

Westchester Medical Center/Maria Fareri Children's Hospital

Valhalla, New York, United States

Children's Hospital of Philadelphia (CHOP)

Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia (Investigational Pharmacy)

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Children's Medical Center Dallas

Dallas, Texas, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=A8081056

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

Other Identifiers

A8081056

Identifier Type: OTHER

Identifier Source: secondary_id

A8081056

Identifier Type: -

Identifier Source: org_study_id