Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT00410358
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2006-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C433984', 'term': 'ST 1481'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2006-12-11', 'studyFirstSubmitQcDate': '2006-12-11', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Maximum Tolerated Dose of gimatecan', 'timeFrame': '1.8 years'}], 'secondaryOutcomes': [{'measure': 'Safety assessed by adverse events', 'timeFrame': '1.8 years'}, {'measure': 'Characterization of the pharmacokinetic profile of gimatecan', 'timeFrame': '1.8 years'}, {'measure': 'Anti-tumor activity assessed by RECIST', 'timeFrame': '1.8 years'}]}, 'conditionsModule': {'keywords': ['Gimatecan', 'topoisomerase I inhibitor', 'advanced solid tumors'], 'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3945', 'label': 'Results for CLBQ707A1101 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histological or cytological confirmed advanced solid tumors, which have progressed despite standard therapy or for whom no standard therapy exists.\n* Life expectancy of at least 3 months\n* Adequate hematological parameters\n* No major impairment of renal and hepatic function\n\nExclusion Criteria:\n\n* Gastrointestinal dysfunction, such as gastrectomy and malabsorption syndrome that could alter absorption.\n* Patients who have received any investigational compound within the past 28 days.\n* Patients with other antineoplastic therapy within the last 28 days.\n* Patients known to be HIV or hepatitis virus positive, or patients with the presence of active or suspected acute or chronic uncontrolled infection\n* Patients with a history of allergies to the camptothecin family drug.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00410358', 'briefTitle': 'A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.', 'orgStudyIdInfo': {'id': 'CLBQ707A1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LBQ707', 'interventionNames': ['Drug: Gimatecan']}], 'interventions': [{'name': 'Gimatecan', 'type': 'DRUG', 'otherNames': ['LBQ707'], 'armGroupLabels': ['LBQ707']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiba Prefecture', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}