Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2025-12-31 @ 12:26 PM
Study NCT ID:
NCT00496028
Status:
COMPLETED
Last Update Posted:
2010-09-22
First Post:
2007-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study in Patients With Solid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C515233', 'term': 'saracatinib'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-21', 'studyFirstSubmitDate': '2007-07-03', 'studyFirstSubmitQcDate': '2007-07-03', 'lastUpdatePostDateStruct': {'date': '2010-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of AZD0530 in combination with carboplatin and/or paclitaxel regimens with solid tumours by assessment of AEs, physical examination, BP, pulse, ECG, laboratory findings, PFTs and thoracic CT scans.', 'timeFrame': 'Assessed at each visit'}], 'secondaryOutcomes': [{'measure': 'To determine the Maximum Tolerated Dose of AZD0530 when administered in combination with carboplatin and/or paclitaxel by assessment of safety and tolerability data generated for each treatment arm.', 'timeFrame': 'Assessed at each visit'}, {'measure': 'To make a preliminary evaluation of clinical response by assessment of RECIST evaluation, time to progression and serum tumour markers.', 'timeFrame': 'Assessment at end of study'}, {'measure': 'To investigate the PK of AZD0530. paclitaxel and carboplatin when co-administered to patients with solid tumours, by assessment of appropriate PK parameters.', 'timeFrame': 'Predetermined timepoints after dose administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Solid tumors', 'locally advanced or Metastatic Cancer suitable for treatment with carboplatin and/or paclitaxel'], 'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study will comprise 2 parts, a dose escalation phase and a dose expansion phase. The 2 phases are part of a single study and described by this single protocol. Patients entered into the dose escalation phase will not be entered into the expansion phase. All subjects must be suitable for treatment with either carboplatin and/or paclitaxel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Life expectancy \\> 12 weeks\n* Women defined as post-menopausal\n* Male or female patients with locally advanced or metastatic cancer suitable for treatment with carboplatin and/or paclitaxel\n\nExclusion Criteria:\n\n* Inadequate bone marrow reserve\n* Inadequate live function, renal function or low haemoglobin\n* Unresolved toxicity from anti-cancer therapy'}, 'identificationModule': {'nctId': 'NCT00496028', 'briefTitle': 'Phase I Study in Patients With Solid Tumours', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open-label Study to Assess the Safety and Tolerability of AZD0530 in Combination With Carboplatin and/or Paclitaxel Chemotherapy in Patients With Solid Tumours', 'orgStudyIdInfo': {'id': 'D8180C00023'}, 'secondaryIdInfos': [{'id': 'AZD0530 study 23'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD0530 + Paclitaxel', 'interventionNames': ['Drug: AZD0530', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'AZD0530 + Carboplatin', 'interventionNames': ['Drug: AZD0530', 'Drug: Carboplatin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'AZD0530 + Carboplatin + Paclitaxel', 'interventionNames': ['Drug: AZD0530', 'Drug: Carboplatin', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'AZD0530', 'type': 'DRUG', 'description': 'oral tablet', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'intravenous infusion', 'armGroupLabels': ['2', '3']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'intravenous infusion', 'armGroupLabels': ['1', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Research Site', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Oslo', 'country': 'Norway', 'facility': 'Research Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Sutton', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}], 'overallOfficials': [{'name': 'Steinar Aamdal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radium Hospital, Norway'}, {'name': 'Mary Stuart, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mary Stuart, MD - Medical Science Director EPT1', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}