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

NCT02473497

Last updated date
Study Location
Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasm
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Currently receiving crizotinib, another ALK inhibitor, or an investigational product.


- Adult patients who have been previously treated with crizotinib.

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NeoplasmCrizotinib (Xalkori) Expanded Access Protocol For The Treatment Of Adult Or Pediatric Patients
NCT02473497
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Advanced Information
Descriptive Information
Brief Title 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
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.
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Neoplasm
Intervention 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
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.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02473497
Other Study ID Numbers A8081056
A8081056 ( Other Identifier: Alias Study Number )
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020