Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-02 @ 1:11 AM
Study NCT ID:
NCT00095992
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508757', 'term': 'ispinesib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2008-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-03', 'studyFirstSubmitDate': '2004-11-09', 'studyFirstSubmitQcDate': '2004-11-08', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': '4 years'}, {'measure': 'Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is adjusted)', 'timeFrame': '4 years'}, {'measure': 'Molecular correlates on archival tumor specimens and peripheral blood mononuclear cells (PBMCs)', 'timeFrame': '4 years'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adult primary hepatocellular carcinoma', 'advanced adult primary liver cancer', 'localized unresectable adult primary liver cancer', 'recurrent adult primary liver cancer'], 'conditions': ['Liver Cancer']}, 'referencesModule': {'references': [{'pmid': '18196204', 'type': 'RESULT', 'citation': 'Knox JJ, Gill S, Synold TW, Biagi JJ, Major P, Feld R, Cripps C, Wainman N, Eisenhauer E, Seymour L. A phase II and pharmacokinetic study of SB-715992, in patients with metastatic hepatocellular carcinoma: a study of the National Cancer Institute of Canada Clinical Trials Group (NCIC CTG IND.168). Invest New Drugs. 2008 Jun;26(3):265-72. doi: 10.1007/s10637-007-9103-2. Epub 2008 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with locally advanced, recurrent, or metastatic liver cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the efficacy of SB-715992, in terms of response rate and stable disease rate, in patients with locally advanced, recurrent, or metastatic hepatocellular carcinoma.\n* Determine the toxicity of this drug in these patients.\n* Determine the early progression rate and response duration in patients treated with this drug.\n* Determine the pharmacokinetics of this drug in these patients.\n* Correlate pharmacokinetics with safety and efficacy of this drug in these patients.\n* Correlate tumor expression of β-tubulin and kinesin spindle protein with clinical outcomes in patients treated with this drug.\n\nOUTLINE: This is a non-randomized, multicenter study.\n\nPatients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nAll patients are followed at 4 weeks. Patients with ongoing stable or responding disease are followed every 3 months until relapse.\n\nPROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-14 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed hepatocellular carcinoma\n\n * Locally advanced, recurrent, or metastatic disease\n * Histologically confirmed disease must have archival paraffin-fixed tumor specimen available\n* Measurable disease\n\n * At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray, physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan\n * Outside of previously irradiated area\n\n * Patients whose sole site of disease is in a previously irradiated field are eligible provided there is evidence of disease progression OR new lesions documented in the irradiated field\n * Bone metastases are not considered measurable disease\n* Not curable by standard therapies\n* No cholangiocarcinoma\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute granulocyte count ≥ 1,500/mm\\^3\n* Platelet count ≥ 80,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 2 times upper limit of normal (ULN)\n* AST ≤ 5 times ULN\n* Must have hepatic reserve of Child-Turcotte-Pugh class A or better\n\nRenal\n\n* Creatinine clearance ≥ 60 mL/min\n\nCardiovascular\n\n* No myocardial infarction within the past 6 months\n* No symptomatic congestive heart failure\n* No unstable angina pectoris\n* No cardiac arrhythmia\n* No active cardiomyopathy\n* No uncontrolled hypertension\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No clinical evidence of encephalopathy\n* No ongoing or active infection\n* No history of allergic reaction attributed to compounds of similar chemical or biological composition to SB-715992\n* No psychiatric illness or social situation that would preclude study compliance\n* No other uncontrolled illness\n* No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for at least 5 years\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* At least 4 weeks since prior intra-hepatic chemotherapy as a component of trans-arterial chemoembolization and recovered\n\n * Documented disease progression\n* No prior systemic chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* See Disease Characteristics\n* At least 4 weeks since prior radiotherapy\n\n * Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy\n\nSurgery\n\n* At least 4 weeks since prior major surgery\n* Prior liver transplantation allowed\n\nOther\n\n* No other prior systemic therapy\n* At least 4 weeks since prior local ablative therapy (e.g., radiofrequency ablation or ethanol injection) and recovered\n\n * Documented disease progression\n* More than 28 days since prior investigational agents\n* More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:\n\n * Clarithromycin\n * Erythromycin\n * Troleandomycin\n * Itraconazole\n * Ketoconazole\n * Fluconazole (dose \\> 200 mg/day)\n * Voriconazole\n * Nefazodone\n * Fluvoxamine\n * Verapamil\n * Diltiazem\n * Grapefruit juice\n * Bitter orange\n * Phenytoin\n * Carbamazepine\n * Phenobarbital\n * Oxcarbazepine\n * Rifampin\n * Rifabutin\n * Rifapentine\n * Hypericum perforatum (St. John's wort)\n * Modafinil\n* At least 6 months since prior and no concurrent amiodarone\n* No concurrent combination antiretroviral therapy for HIV-positive patients\n* No other concurrent anticancer therapy\n* No other concurrent investigational agents"}, 'identificationModule': {'nctId': 'NCT00095992', 'briefTitle': 'SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Phase II Study Of SB-715992 (NSC 727990) In Patients With Locally Advanced, Recurrent Or Metastatic Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'I168'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-IND168', 'type': 'OTHER', 'domain': 'PDQ'}, {'id': 'CDR0000391839', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ispinesib', 'type': 'DRUG', 'description': 'SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BCCA - Vancouver Cancer Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre at Hamilton Health Sciences', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K7L 5P9', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Centre of Southeastern Ontario at Kingston', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Univ. Health Network-Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jennifer Knox, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Margaret Hospital, Canada'}, {'name': 'Sharlene Gill, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'British Columbia Cancer Agency'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}