Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-03-03 @ 2:19 AM
Study NCT ID:
NCT00982267
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2009-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Of SU14813 In Patients With Advanced Solid Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-04', 'studyFirstSubmitDate': '2009-09-22', 'studyFirstSubmitQcDate': '2009-09-22', 'lastUpdatePostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': '18-Nov-2008'}], 'secondaryOutcomes': [{'measure': 'Determine the recommended Phase 2 dose (RP2D)', 'timeFrame': '18-Nov-2008'}, {'measure': 'Preliminary information on SU014813 anti-tumor effect;', 'timeFrame': '18-Nov-2008'}, {'measure': 'Plasma pharmacokinetics', 'timeFrame': '18-Nov-2008'}, {'measure': 'Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa', 'timeFrame': '18-Nov-2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer'], 'conditions': ['Neoplasms', 'Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '20605934', 'type': 'DERIVED', 'citation': 'Fiedler W, Giaccone G, Lasch P, van der Horst I, Brega N, Courtney R, Abbattista A, Shalinsky DR, Bokemeyer C, Boven E. Phase I trial of SU14813 in patients with advanced solid malignancies. Ann Oncol. 2011 Jan;22(1):195-201. doi: 10.1093/annonc/mdq313. Epub 2010 Jul 6.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=RTKD-7840-002&StudyName=A%20Trial%20Of%20SU14813%20In%20Patients%20With%20Advanced%20Solid%20Malignancies', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function\n\nExclusion Criteria:\n\n* Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment\n* Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.'}, 'identificationModule': {'nctId': 'NCT00982267', 'briefTitle': 'A Trial Of SU14813 In Patients With Advanced Solid Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase I Dose Escalating Study Of SU014813 In Patients With Solid Tumors Not Amenable To Conventional Therapy', 'orgStudyIdInfo': {'id': 'RTKD-7840-002'}, 'secondaryIdInfos': [{'id': 'A6191002'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SU014813', 'interventionNames': ['Drug: SU014813']}], 'interventions': [{'name': 'SU014813', 'type': 'DRUG', 'description': 'Escalating doses of SU014813 from 50 to 250mg/day . Capsules administered daily either as continuous dosing or in cycles of 4 weeks on 1 week off', 'armGroupLabels': ['SU014813']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}