Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC


Last updated date
Study Location
Aichi cancer center central hospital
Nagoya, Aichi, 464-8681, Japan


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms, Non-Small-Cell Lung Carcinoma
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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


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Neoplasms, Non-Small-Cell Lung CarcinomaCrizotinib Expanded Access Protocol For ROS1 Positive NSCLC
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Advanced Information
Descriptive Information
Brief Title Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC
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.
Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: crizotinib
Crizotinib, 250 mg BID, will be administered orally on a continuous daily dosing schedule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status No longer available
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
Administrative Information
NCT Number NCT02824094
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Study Director:Pfizer Call CenterPfizer
PRS Account Pfizer
Verification Date July 2017