Clinical trial NCT02473497: Crizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric 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
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Neoplasm
Keywords: chromosomal rearrangement
activating mutation
activating genetic alteration
genetic aberration
ALK
ROS1
cMET
crizotinib
oral formulation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-06-16
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Hawthorne
country: United States
facility: West Chester Medical Center
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of New York
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center/Maria Fareri Children's Hospital
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia (CHOP)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia (Investigational Pharmacy)
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: