Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00060151
Status:
COMPLETED
Last Update Posted:
2013-09-20
First Post:
2003-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GW786034 in Treating Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-04', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2003-05-06', 'studyFirstSubmitQcDate': '2003-05-06', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-05-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and toxicity assessed weekly during treatment'}], 'secondaryOutcomes': [{'measure': 'Disease response every 9 weeks'}]}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '19509175', 'type': 'RESULT', 'citation': 'Hurwitz HI, Dowlati A, Saini S, Savage S, Suttle AB, Gibson DM, Hodge JP, Merkle EM, Pandite L. Phase I trial of pazopanib in patients with advanced cancer. Clin Cancer Res. 2009 Jun 15;15(12):4220-7. doi: 10.1158/1078-0432.CCR-08-2740. Epub 2009 Jun 9.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of GW786034 in treating patients with advanced solid tumors.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and tolerability of GW786034 in patients with advanced solid tumors.\n* Determine the maximum tolerated dose of this drug in these patients.\n* Determine the pharmacokinetics of this drug in these patients.\n* Determine the clinical response in patients treated with this drug.\n* Evaluate the effect of this drug on biomarkers of angiogenesis activity in order to estimate activity and to determine the minimum biologically active dose in these patients.\n\nOUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.\n\nPatients receive oral GW786034 twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nCohorts of 2-6 patients receive escalating doses of GW786034 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.\n\nPatients are followed at 21 days.\n\nPROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed advanced solid tumor\n* Refractory to standard therapy or for which no standard therapy exists\n* No untreated leptomeningeal or brain metastases\n\n * Previously treated brain metastases are allowed if currently asymptomatic and patient is off steroids and antiseizure medications for more than 3 months before study entry\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 21 and over\n\nPerformance status\n\n* Karnofsky 70-100%\n\nLife expectancy\n\n* At least 12 weeks\n\nHematopoietic\n\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n* Hemoglobin at least 9 g/dL\n\nHepatic\n\n* Bilirubin no greater than 1.5 mg/dL\n* AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if tumor involvement)\n\nRenal\n\n* Creatinine clearance at least 60 mL/min\n\nCardiovascular\n\n* No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg on 2 consecutive measurements separated by 1 week)\n* No arterial or venous thrombosis (including cerebrovascular accident) within the past 3 months\n* No myocardial infarction within the past 3 months\n* No unstable angina within the past 3 months\n* No cardiac angiopathy or stenting within the past 3 months\n* No cardiac pacemaker\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 21 days after study treatment\n* Able to swallow and retain oral medication\n* Good venous access\n* No prior or concurrent gastrointestinal disease\n* No prior or concurrent condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs\n* No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug\n* No other unstable, pre-existing major medical condition\n* No orthopedic pins or rods or other embedded metal that would preclude undergoing an MRI\n* No psychological, familial, sociological, or geographical condition that would preclude study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 4 weeks since prior immunotherapy\n* Concurrent epoetin alfa allowed\n* No concurrent anticancer biologic therapy\n\nChemotherapy\n\n* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)\n* No concurrent anticancer cytotoxic chemotherapy\n\nEndocrine therapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior hormonal or steroid therapy (other than replacement)\n* No concurrent anticancer hormonal therapy (except for replacement)\n* No concurrent dexamethasone or prednisone\n\nRadiotherapy\n\n* More than 4 weeks since prior radiotherapy\n* No concurrent anticancer radiotherapy\n\nSurgery\n\n* More than 4 weeks since prior major surgery\n* No concurrent surgery for cancer\n\nOther\n\n* Recovered from prior therapy\n* More than 4 weeks since prior investigational agents\n* More then 28 days since prior alteration of antihypertensive medications\n* Concurrent bisphosphonates allowed\n* No other concurrent anticancer therapy\n* No concurrent antidepressants (e.g., amitriptyline, fluoxetine, or fluvoxamine)\n* No concurrent oral hypoglycemics (e.g., glipizide, glyburide, rosiglitazone, or tolbutamide)\n* No concurrent therapeutic anticoagulation (e.g., warfarin at therapeutic doses)\n\n * Low-dose anticoagulation for prophylaxis allowed\n* No concurrent cyclosporine\n* No concurrent grapefruit juice\n* No concurrent amiodarone, mibefradil, phenobarbital, or pioglitazone\n* No concurrent Hypericum perforatum (St. John's Wort)\n* No concurrent rifabutin or diethyldithiocarbamate\n* No concurrent gestodene, mifepristone, or modafinil\n* No concurrent herbal supplements, vitamins, or non-traditional compounds"}, 'identificationModule': {'nctId': 'NCT00060151', 'briefTitle': 'GW786034 in Treating Patients With Advanced Solid Tumors', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I, Open Label, Multiple Dose, Dose Escalation Study OF GW786034 In Patients With Solid Tumors', 'orgStudyIdInfo': {'id': 'CDR0000299531'}, 'secondaryIdInfos': [{'id': 'CASE-CWRU-100231'}, {'id': 'GSK-VEG10003'}, {'id': 'GSK-RM2002/00345/02'}, {'id': 'CWRU-GLAX-1Y02'}, {'id': 'CWRU-1Y02'}, {'id': 'CASE-100231'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'pazopanib hydrochloride', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Afshin Dowlati, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}