Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-27 @ 1:31 AM
Study NCT ID:
NCT00503204
Status:
COMPLETED
Last Update Posted:
2009-11-25
First Post:
2007-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500926', 'term': 'cediranib'}, {'id': 'D008130', 'term': 'Lomustine'}], 'ancestors': [{'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-24', 'studyFirstSubmitDate': '2007-07-16', 'studyFirstSubmitQcDate': '2007-07-16', 'lastUpdatePostDateStruct': {'date': '2009-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.', 'timeFrame': 'Assessed at each visit'}], 'secondaryOutcomes': [{'measure': 'Compare the pharmacokinetics of cediranib alone versus when in combination with lomustine as measured by minimum steady state plasma concentration (Css,min) steady-state plasma concentration', 'timeFrame': 'assessed 2 & 4 hours post dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'tumor', 'advance solid tumour', 'glioblastoma', 'malignant brain tumour'], 'conditions': ['Recurrent Glioblastoma', 'Brain Tumor']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open-label, multi-centre study designed to assess the safety and tolerability of Cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary recurrent malignant brain tumour for whom lomustine would be standard therapy - diagnosis \\& stage\n* Patients received no more than 2 previous systemic chemotherapy regimes\n* Life Expectancy \\> 12 weeks\n* Patients must be at least 3 months from the completion of cranial radiation therapy\n\nExclusion Criteria:\n\n* History of poorly controlled high blood pressure\n* Recent major surgery prior to entry into the study'}, 'identificationModule': {'nctId': 'NCT00503204', 'briefTitle': 'Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open Label, Multi-Centre Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Lomustine Chemotherapy for Patients With Primary Recurrent Malignant Brain Tumours for Whom Lomustine Would be a Standard Therapy', 'orgStudyIdInfo': {'id': 'D8480C00057'}, 'secondaryIdInfos': [{'id': 'EuDract 2007-000909-30'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Lomustine + Cediranib (AZD2171)', 'interventionNames': ['Drug: Cediranib', 'Drug: Lomustine']}], 'interventions': [{'name': 'Cediranib', 'type': 'DRUG', 'otherNames': ['RECENTIN™', 'AZD2171'], 'description': 'oral tablet', 'armGroupLabels': ['1']}, {'name': 'Lomustine', 'type': 'DRUG', 'otherNames': ['CCNU', 'CeeNU®'], 'description': 'oral capsule', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Jane Robertson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Tracy Batchelor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jane Robertson, Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}