Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00516802
Status:
COMPLETED
Last Update Posted:
2009-05-15
First Post:
2007-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C531550', 'term': 'olaparib'}, {'id': 'D003606', 'term': 'Dacarbazine'}], 'ancestors': [{'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-14', 'studyFirstSubmitDate': '2007-08-13', 'studyFirstSubmitQcDate': '2007-08-13', 'lastUpdatePostDateStruct': {'date': '2009-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine.', 'timeFrame': 'assessed every 3 weeks'}], 'secondaryOutcomes': [{'measure': 'Objective tumour response', 'timeFrame': 'assessed every 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Poly(ADP ribose) polymerases', 'dacarbazine'], 'conditions': ['Melanoma Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who have not previously received systemic cytotoxic chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have:\n\n 1. Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases.\n 2. Histological or cytological confirmation of melanoma. Histological confirmation of melanoma from the primary site will suffice, unless the primary site is unknown.\n\nExclusion Criteria:\n\n* Previous treatment with cytotoxic chemotherapy for advanced melanoma, apart from treatment for melanoma with isolated limb perfusion.\n* Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).\n* Major surgery within 4 weeks of starting the study.'}, 'identificationModule': {'nctId': 'NCT00516802', 'briefTitle': 'A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 and Dacarbazine in the Treatment of Patients With Advanced Solid Tumours', 'orgStudyIdInfo': {'id': 'KU36-73'}, 'secondaryIdInfos': [{'id': 'D0810C00003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'DTIC + KU-0059436', 'interventionNames': ['Drug: KU-0059436 (AZD2281)(PARP inhibitor)', 'Drug: dacarbazine']}], 'interventions': [{'name': 'KU-0059436 (AZD2281)(PARP inhibitor)', 'type': 'DRUG', 'otherNames': ['Olaparib'], 'description': 'oral', 'armGroupLabels': ['1']}, {'name': 'dacarbazine', 'type': 'DRUG', 'otherNames': ['DTIC'], 'description': 'intravenous injection over at least 20 minutes', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Prof James Carmichael, BSc MBChB MD FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'KuDOS Pharmaceuticals Ltd'}, {'name': 'Prof Martin Gore, PhD MRCP FRCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Marsden Hospital Trust, London, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'KuDOS Pharmaceuticals Limited', 'class': 'INDUSTRY'}]}}}