Solid tumors
Conditions
Interventions
Trade Name: Xalkori
Product Name: Crizotinib
Product Code: PF-02341066
Pharmaceutical Form: Oral solution
INN or Proposed INN: Crizotinib
CAS Number: 877399-52-5
Current Sponsor code: PF-02341066
Conc
Sponsors
Pfizer, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Currently receiving an ALK inhibitor other than crizotinib, or an investigational product. - Patients who are eligible to participate in other crizotinib studies using the oral liquid formulation of crizotinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To use expanded access to evaluate the safety of an alternative oral formulation (the oral liquid formulation and coated microsphere formulation ) of crizotinib in up to approximately 40 patients with tumors harboring either a chromosomal translocation or activating mutation involving the ALK or ROS1 gene or an activating genetic alteration involving the c-MET gene, who have a genetic aberration involving ALK, ROS1, or c-MET but who cannot swallow crizotinib capsules. ;Secondary Objective: Not Applicable;Primary end point(s): All Serious Adverse Events and Grade 3-5 adverse events as assessed by CTCAE v4.03;Timepoint(s) of evaluation of this end point: Up to 28 days after end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer, Inc.
Outcome results
None listed