Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00732420
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2008-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}, {'id': 'C516667', 'term': 'pazopanib'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2013-06-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-08', 'studyFirstSubmitDate': '2008-08-11', 'studyFirstSubmitQcDate': '2008-08-11', 'lastUpdatePostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First course tolerability with rising dose of topotecan to determine the maximum tolerated dose of topotecan when given with pazopanib daily.', 'timeFrame': '5 weeks'}], 'secondaryOutcomes': [{'measure': 'Indications of efficacy through tumour shrinkage. Specific biomarker analysis.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pazopanib', 'Phase I', 'topotecan', 'Advanced Solid Tumors'], 'conditions': ['Solid Tumours']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/HYT109091?search=study&study_ids=HYT109091#rs', 'label': 'Results for study HYT109091 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'To determined what dose of topotecan can be safely given with daily pazopanib.', 'detailedDescription': 'A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in combination with Pazopanib in Subjects with Advanced Solid Tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria -\n\n* signed, written informed consent.\n* at least 18 years of age.\n* ECOG performance status 0 or 1.\n* Subjects must have histologically or cytologically confirmed diagnosis of advanced cancer and a solid tumor malignancy that has relapsed or is refractory to standard therapy or for which there is no established therapy.\n* able to swallow and retain oral medications.\n* females are eligible to enter and participate in this study providing adequate established contraception is being practiced.\n\nExclusion Criteria\n\n* had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C)\n* received an investigational drug within 30 days or 5 half-lives (whichever is longer).\n* received prior treatment with pazopanib/investigational anti-angiogenic compounds.\n* presence of uncontrolled infection.\n* pregnant or lactating.\n* poorly controlled hypertension (SBP of ? 140 mmHg, or DBP of ? 90 mmHg.\n* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.-\n* arterial thrombi, myocardial infarction, admission for unstable angina, uncontrolled or symptomatic arrhythmia, cardiac angioplasty, or stenting within the last 6 months.\n* any unresolved bowel obstruction or diarrhea ? Grade 1.\n* received an allogeneic bone marrow transplant.\n* known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or topotecan.\n* any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance with the study.\n* psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.\n* clinical history, current alcohol or illicit drug use which, in the judgment of the investigator, would interfere with the subject's ability to comply with the dosing schedule and protocol-specified evaluations."}, 'identificationModule': {'nctId': 'NCT00732420', 'briefTitle': 'Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase I Open-label Study of the Safety, Tolerability, and Pharmacokinetics of Two Schedules of Oral Topotecan in Combination With Pazopanib in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'HYT109091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm A', 'description': 'Daily oral pazopanib in combination with weekly oral topotecan. Initially rising dose to determine the maximum tolerated dose: finally an expanded cohort treated at the maximum tolerated dose.', 'interventionNames': ['Drug: topotecan', 'Drug: pazopanib']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm B', 'description': 'Daily oral pazopanib in combination with oral topotecan given for 5 consecutive days every 21 days. Initially rising dose to determine the maximum tolerated dose; finally an additional cohort of patients treated at the maximum tolerated dose.', 'interventionNames': ['Drug: topotecan', 'Drug: pazopanib']}], 'interventions': [{'name': 'topotecan', 'type': 'DRUG', 'description': 'Topoisomerase I inhibition.', 'armGroupLabels': ['Treatment Arm A', 'Treatment Arm B']}, {'name': 'pazopanib', 'type': 'DRUG', 'description': 'Tyrosine kinase inhibitor', 'armGroupLabels': ['Treatment Arm A', 'Treatment Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}