Clinical trial NCT02824094: Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC
Official title: Crizotinib (Xalkori (Registered)) Expanded Access Protocol For The Treatment Of Japanese Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Ros1 Oncogene
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Neoplasms
Carcinoma, Non-Small-Cell Lung
Keywords: Expanded Access Protocol
crizotinib
Xalkori
ROS1
Japanese
A8081064
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-07-06
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Primary objective of this study is to allow access and evaluate the safety of crizotinib for patients in Japan with advanced NSCLC harboring a translocation or inversion involving the ROS1 oncogene.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.
* Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.
* ECOG performance status 0 to 2.
* Adequate organ function
* Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.
* Male patients able to father children and female patients of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for at least 90 days after the last dose of crizotinib.

Exclusion Criteria:

* Currently receiving crizotinib or any investigational products.
* Prior therapy specifically directed against ROS1 fusion genes including crizotinib.
* Carcinomatous meningitis or leptomeningeal disease.
* Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.
* Ongoing uncontrolled congestive heart failure (CHF) and any of the following within the 3 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack.
* Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QTc more than 480 msec.
* History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease, including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis, but not history of prior radiation pneumonitis.
* Pregnant female patients; breastfeeding female patients.
* Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4 inducers and CYP3A4 substrates with narrow therapeutic indices

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi cancer center central hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Akashi
country: Japan
facility: Hyogo Cancer Center
state: Hyogo
city: Koto-ku, Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: