Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT00742261
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2008-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors
Sponsor:
Organization:
Raw JSON
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A comparison of the pharmacokinetics of the anticancer MET inhibitor foretinib free base tablet formulation to bisphosphate salt capsule formulation in patients with solid tumors. Invest New Drugs. 2012 Feb;30(1):327-34. doi: 10.1007/s10637-010-9536-x. Epub 2010 Sep 15.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}, {'url': 'https://gsk-clinicalstudyregister.com/study/MET111516?search=study&study_ids=111516#rs', 'label': 'Results for study MET111516 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'Study to compare 2 different chemical forms of GSK1363089.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of solid tumor malignancy.\n* 18 years old with ECOG of 0-1.\n* female subject who is not pregnant\n* Male subjects must agree to use contraception methods\n* Able to swallow and retain oral medication.\n* The subject will refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.\n* QTcB or QTcF \\< 470 msec.\n* Bilirubin = 1.5mg/dl, AST, ALT, ALP \\<2X ULN in absence of malignant disease in the liver or \\<5X ULN in case of liver involvement by the tumor.\n* Serum Creatinine \\<1.5mg/dL\n\nExclusion Inclusion:\n\n* The subject has received anticancer treatment.\n* The subject has participated in a clinical trial and has received an investigational product within 21 days.\n* The subject has known brain metastases.\n* The subject has uncontrolled intercurrent illness.\n* History of sensitivity to any of the study medications, or components.\n* The subject is known to be positive for the human immunodeficiency virus (HIV).\n* Subjects who have had partial or complete gastrectomy.\n* Pregnant females as determined by positive ß-hCG test at screening or prior to dosing.\n* Lactating females.\n* Unwillingness or inability to follow the procedures outlined in the protocol.'}, 'identificationModule': {'nctId': 'NCT00742261', 'briefTitle': 'A Bioavailability Study of GSK1363089 in Subjects With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of Two Forms ofGSK1363089 in Subjects With Solid Tumors', 'orgStudyIdInfo': {'id': 'MET111516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK1363089', 'description': 'Two-part study to evlauate the relative bioavailability of GSK1363089 from a free base formulation (GSK1363089G) compared with the biophosphate salt formulation (GSK1363089A) (Part 1) and to assess the safety of the GSK1363089 biophosphate formulation when administered three times a week until disease progression (Part 2).', 'interventionNames': ['Drug: GSK1363089']}], 'interventions': [{'name': 'GSK1363089', 'type': 'DRUG', 'otherNames': ['GSK1363089G', 'GSK1363089A'], 'description': 'Two-part study to evlauate the relative bioavailability of GSK1363089 from a free base formulation (GSK1363089G) compared with the biophosphate salt formulation (GSK1363089A) (Part 1) and to assess the safety of the GSK1363089 biophosphate formulation when administered three times a week until disease progression (Part 2).', 'armGroupLabels': ['GSK1363089']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}