Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00742105
Status:
TERMINATED
Last Update Posted:
2018-09-25
First Post:
2008-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570852', 'term': '8-(6-methoxypyridin-3-yl)-3-methyl-1-(4-piperazin-1-yl-3-trifluoromethylphenyl)-1,3-dihydroimidazo(4,5-c)quinolin-2-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2009-12-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2008-08-25', 'studyFirstSubmitQcDate': '2008-08-26', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicity (DLT) at each dose level', 'timeFrame': '22-28 days'}], 'secondaryOutcomes': [{'measure': 'Safety measured by type, frequency and severity of adverse drug reactions', 'timeFrame': 'Every 4 weeks', 'description': 'Safety measures by Common Terminology Criteria for Adverse Events (CTCAE)'}, {'measure': 'Preliminary Efficacy od BGT226', 'timeFrame': 'Every 8 weeks', 'description': 'Measured by Response Evaluation criteria in Solid Tumors (RECIST)'}, {'measure': 'Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling', 'timeFrame': 'Baseline, every 3 weeks'}, {'measure': 'Biomarkers: Percentage of change, pre- versus post-treatment', 'timeFrame': 'Every month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PI3K', 'mTOR', 'Advanced solid tumor', 'Adult'], 'conditions': ['Cancer', 'Solid Tumor', 'Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* World Health Organization (WHO) Performance Status of ≤ 2\n* Histologically-confirmed, advanced solid tumors\n* Progressive, recurrent unresectable disease\n* Age ≥ 20\n\nExclusion Criteria:\n\n* Hematopoietic:\n* No diabetes mellitus or history of gestational diabetes mellitus\n* No acute or chronic renal disease\n* No acute or chronic liver disease\n* No acute or chronic pancreatitis\n* No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension\n* No acute myocardial infarction or unstable angina pectoris within the past 3 months\n* Not pregnant or nursing and fertile patients must use barrier contraceptives\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00742105', 'briefTitle': 'Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan', 'orgStudyIdInfo': {'id': 'CBGT226A1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BGT226', 'interventionNames': ['Drug: BGT226']}], 'interventions': [{'name': 'BGT226', 'type': 'DRUG', 'armGroupLabels': ['BGT226']}]}, 'contactsLocationsModule': {'locations': [{'zip': '464-8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}