Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-02 @ 10:00 AM
Study NCT ID:
NCT00704366
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2008-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C515233', 'term': 'saracatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2008-06-23', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2011-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to evaluate the safety and tolerability of AZD0530 in Japanese patients with advanced solid malignancies by assessment of AEs, vital signs, ECG, laboratory findings, thoracic imaging and pulmonary function test.', 'timeFrame': 'Assessed on an ongoing basis after starting daily dosing with AZD0530'}], 'secondaryOutcomes': [{'measure': 'To determine the single and multiple dose PK of AZD0530 when administered orally to patients with advanced solid malignancies by assessment of Cmin, Cmax, tmax, Cssmax, Cssmin, AUC0-t, AUC0-24, AUC, AUCss0-24, CL/F, t1/2 and R', 'timeFrame': '1 blood sample before the single dose and 11 samples afterwards until up to 146 hours after dose.1 blood sample before the start of daily dosing of AZD0530. With a further 12 samples over the next 22 days.'}, {'measure': 'Tumor response', 'timeFrame': 'at entry and then 6 and 12 weeks after starting daily dosing of AZD0530. Assesments will then be made every 9 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Advanced carcinoma'], 'conditions': ['Solid Tumor']}, 'referencesModule': {'references': [{'pmid': '22415795', 'type': 'DERIVED', 'citation': 'Fujisaka Y, Onozawa Y, Kurata T, Yasui H, Goto I, Yamazaki K, Machida N, Watanabe J, Shimada H, Shi X, Boku N. First report of the safety, tolerability, and pharmacokinetics of the Src kinase inhibitor saracatinib (AZD0530) in Japanese patients with advanced solid tumours. Invest New Drugs. 2013 Feb;31(1):108-14. doi: 10.1007/s10637-012-9809-7. Epub 2012 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists\n* World Health Organisation (WHO) performance status 0 to 2\n* Life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Inadequate bone marrow reserve\n* Inadequate liver function, renal function or low hemoglobin\n* Unresolved toxicity from anti-cancer therapy'}, 'identificationModule': {'nctId': 'NCT00704366', 'briefTitle': 'AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open-label, Dose-escalation Study to Assess the Safety and Tolerability of AZD0530 in Patients With Advanced Solid Malignancies', 'orgStudyIdInfo': {'id': 'D8180C00021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD0530', 'interventionNames': ['Drug: AZD0530']}], 'interventions': [{'name': 'AZD0530', 'type': 'DRUG', 'description': 'oral, tablet, once daily, dose will be variable', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Takatsuk', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Sunto-gun', 'state': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'Mary Stuart, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca'}, {'name': 'Narikazu Boku, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint Marianna University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Mary Stuart, BSc MSc MB BCh BAO MRCPI, Medical Science Director Emerging Oncology Product Team 1', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}