Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT02824094
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-07-21
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077547', 'term': 'Crizotinib'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Expanded Access Protocol', 'crizotinib', 'Xalkori', 'ROS1', 'Japanese', 'A8081064'], 'conditions': ['Neoplasms', 'Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8081064&StudyName=Crizotinib+%28xalkori+%28registered%29%29+Expanded+Access+Protocol+For+The+Treatment+Of+Japanese+Patients+With+Advanced+Non-small+Cell+Lung+Cancer+%28nsclc%29+Harboring+A+Translocation+Or+Inversion+Involving+The+Ros1+Oncogene', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic.\n* Positive for translocation or inversion events involving the ROS1 gene as determined by protocol defined test.\n* ECOG performance status 0 to 2.\n* Adequate organ function\n* Patients with brain metastases are eligible if neurologically stable for at least 2 weeks and have no ongoing requirement for corticosteroids.\n* 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.\n\nExclusion Criteria:\n\n* Currently receiving crizotinib or any investigational products.\n* Prior therapy specifically directed against ROS1 fusion genes including crizotinib.\n* Carcinomatous meningitis or leptomeningeal disease.\n* Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function.\n* 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.\n* Ongoing cardiac dysrhythmias of CTCAE Grade 2, uncontrolled atrial fibrillation of any grade, or QTc more than 480 msec.\n* 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.\n* Pregnant female patients; breastfeeding female patients.\n* Use of drugs or foods including known potent CYP3A4 inhibitors, known potent CYP3A4 inducers and CYP3A4 substrates with narrow therapeutic indices'}, 'identificationModule': {'nctId': 'NCT02824094', 'briefTitle': 'Crizotinib Expanded Access Protocol For ROS1 Positive NSCLC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'A8081064'}}, 'armsInterventionsModule': {'interventions': [{'name': 'crizotinib', 'type': 'DRUG', 'description': 'Crizotinib, 250 mg BID, will be administered orally on a continuous daily dosing schedule'}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Aichi cancer center central hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277-8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'National Cancer Center Hospital East', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '673-8558', 'city': 'Akashi', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Hyogo Cancer Center', 'geoPoint': {'lat': 34.65524, 'lon': 135.00687}}, {'zip': '135-8550', 'city': 'Koto-ku, Tokyo', 'country': 'Japan', 'facility': 'The Cancer Institute Hospital of JFCR'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}