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Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Aichi cancer center central hospital
Nagoya, Aichi, 464-8681 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms, Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
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.
Show details

- 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.
Show details

- 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

NCT02824094
Pfizer
No longer available
Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

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Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC
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.
Not Provided
Expanded Access
Drug: crizotinib
Crizotinib, 250 mg BID, will be administered orally on a continuous daily dosing schedule
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT02824094
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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