Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-01 @ 8:06 PM
Study NCT ID:
NCT00033566
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2002-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-3304 in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C503948', 'term': 'S 3304'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-03', 'studyFirstSubmitDate': '2002-04-09', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '17404091', 'type': 'RESULT', 'citation': "Chiappori AA, Eckhardt SG, Bukowski R, Sullivan DM, Ikeda M, Yano Y, Yamada-Sawada T, Kambayashi Y, Tanaka K, Javle MM, Mekhail T, O'bryant CL, Creaven PJ. A phase I pharmacokinetic and pharmacodynamic study of s-3304, a novel matrix metalloproteinase inhibitor, in patients with advanced and refractory solid tumors. Clin Cancer Res. 2007 Apr 1;13(7):2091-9. doi: 10.1158/1078-0432.CCR-06-1586."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor.\n\nPURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors.\n* Determine the pharmacokinetic profile of this drug in these patients.\n* Estimate the starting dose of this drug for subsequent phase II efficacy studies.\n\nOUTLINE: This is a dose-escalation, multicenter study.\n\nPatients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity.\n\nPatients are followed at 30 days.\n\nPROJECTED ACCRUAL: A total of 6-28 patients will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists\n* Biopsy-accessible lesion\n* No brain metastasis unless clinically stable and off therapy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* More than 6 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count greater than 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 9.0 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 2 times upper limit of normal (ULN)\n* Transaminases less than 2.5 times ULN\n\nRenal:\n\n* Creatinine less than 2.0 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for at least 30 days after study\n* Able to tolerate oral medication\n* HIV negative\n* No AIDS\n* No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease)\n* No other serious concurrent illness\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 4 weeks since prior immunotherapy\n* Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses\n* No other concurrent immunotherapy\n\nChemotherapy:\n\n* At least 4 weeks since prior chemotherapy\n* No concurrent chemotherapy\n\nEndocrine therapy:\n\n* At least 4 weeks since prior hormonal therapy\n* Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses\n* No concurrent hormonal therapy\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy\n* No concurrent radiotherapy\n\nSurgery:\n\n* No prior significant gastric resection\n\nOther:\n\n* Recovered from prior therapy\n* At least 4 weeks since other prior investigational antitumor drugs\n* No other concurrent investigational antitumor drugs\n* Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses'}, 'identificationModule': {'nctId': 'NCT00033566', 'briefTitle': 'S-3304 in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Phase I Study of S-3304 in Patients With Solid Tumors', 'orgStudyIdInfo': {'id': 'CDR0000069301'}, 'secondaryIdInfos': [{'id': 'RPCI-DS-0120'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'S-3304', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Patrick J. Creaven, MBBS, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Patrick Creaven, MD', 'oldOrganization': 'Roswell Park Cancer Institute'}}}}