Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-02-19 @ 5:33 AM
Study NCT ID:
NCT01110668
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2010-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C498826', 'term': 'nilotinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2010-04-22', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.', 'timeFrame': 'every 8 weeks'}], 'secondaryOutcomes': [{'measure': 'To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['Unresectable', 'metastatic gastrointestinal stromal tumor', 'disease progression', 'progression-free survival'], 'conditions': ['Gastrointestinal Stromal Tumor']}, 'descriptionModule': {'briefSummary': 'This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic\n* Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose\n* At least one measurable site of disease on CT scan at Visit-2\n* WHO Performance Status of 0, 1 or 2 at Visit-2\n* Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2\n\nExclusion Criteria:\n\n* Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.\n* Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks\n* Prior or concomitant malignancies other than GIST\n* Impaired cardiac function at Visit-1 or 2\n* Patients with severe and/or uncontrolled concurrent medical disease\n* Use of therapeutic coumarin derivatives\n* Use of any medications that prolong the QT interval\n* Use of CYP3A4 inhibitors\n* Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery\n* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \\< 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01110668', 'briefTitle': 'Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Previously Treated With Imatinib', 'orgStudyIdInfo': {'id': 'CAMN107DTR01T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nilotinib', 'interventionNames': ['Drug: Nilotinib']}], 'interventions': [{'name': 'Nilotinib', 'type': 'DRUG', 'armGroupLabels': ['Nilotinib']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}