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Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC

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ClinicalTrials.gov Identifier: NCT02824094
Recruitment Status : No longer available
First Posted : July 6, 2016
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Neoplasms Carcinoma, Non-Small-Cell Lung Drug: crizotinib

Study Type : Expanded Access
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

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib
U.S. FDA Resources


Intervention Details:
    Drug: crizotinib
    Crizotinib, 250 mg BID, will be administered orally on a continuous daily dosing schedule

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824094


Locations
Japan
Aichi cancer center central hospital
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
Hyogo Cancer Center
Akashi, Hyogo, Japan, 673-8558
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02824094     History of Changes
Other Study ID Numbers: A8081064
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by Pfizer:
Expanded Access Protocol
crizotinib
Xalkori
ROS1
Japanese
A8081064

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Crizotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action