Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-07 @ 6:57 AM
Study NCT ID:
NCT00687934
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2008-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533237', 'term': 'STA 9090'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2008-05-28', 'studyFirstSubmitQcDate': '2008-05-30', 'lastUpdatePostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities', 'timeFrame': 'Cycle 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic cancer', 'solid tumor', 'histologically or cytologically confirmed non-hematological', 'malignancy that is metastatic or unresectable for which no', 'standard therapy exists', 'STA-9090', 'ganetespib'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '23530663', 'type': 'DERIVED', 'citation': 'Goldman JW, Raju RN, Gordon GA, El-Hariry I, Teofilivici F, Vukovic VM, Bradley R, Karol MD, Chen Y, Guo W, Inoue T, Rosen LS. A first in human, safety, pharmacokinetics, and clinical activity phase I study of once weekly administration of the Hsp90 inhibitor ganetespib (STA-9090) in patients with solid malignancies. BMC Cancer. 2013 Mar 25;13:152. doi: 10.1186/1471-2407-13-152.'}]}, 'descriptionModule': {'briefSummary': 'An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be documented to be refractory or not candidates for current approved therapies.\n* Must have an ECOG status 0-2.\n* Peripheral neuropathy \\< or = 2.\n* Must have acceptable organ and marrow function per protocol parameters.\n* No clinically significant ventricular arrythmias or ischemia.\n\nExclusion Criteria:\n\n* Must not be pregnant or breastfeeding.\n* Chemotherapy or radiation within 3 weeks.\n* Previous radiation to \\>25% of total bone marrow.\n* Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation.\n* Primary brain tumors or active brain metastases.\n* Use of any investigational agents within 4 weeks.\n* Treatment with chronic immunosuppressants.\n* Uncontrolled, intercurrent illness.'}, 'identificationModule': {'nctId': 'NCT00687934', 'briefTitle': 'Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synta Pharmaceuticals Corp.'}, 'officialTitle': 'A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors', 'orgStudyIdInfo': {'id': '9090-02'}, 'secondaryIdInfos': [{'id': '9090-02'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ganetespib', 'description': 'Ganetespib once weekly infusion, dose escalation study, with treatment until progression', 'interventionNames': ['Drug: STA-9090']}], 'interventions': [{'name': 'STA-9090', 'type': 'DRUG', 'description': 'This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.', 'armGroupLabels': ['Ganetespib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404-2111', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Premiere Oncology', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '45409', 'city': 'Kettering', 'state': 'Ohio', 'country': 'United States', 'facility': 'US Oncology Dayton Oncology and Hematology, P.A', 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synta Pharmaceuticals Corp.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}