Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT00536835
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2007-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561573', 'term': 'GSK 461364'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2009-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-23', 'studyFirstSubmitDate': '2007-09-27', 'studyFirstSubmitQcDate': '2007-09-27', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma levels for GSK461364 will be taken at:Schedule 1:Day 1, 8, 15, & 22 for Cycle 1 and Day 1, 8 & 15 for subsequent cycles.Schedule 2:Day 1, 2, 8, 9, 15, & 16 for all cycles.Schedule 3:Day 1 to 5 for all cycles.', 'timeFrame': '16 Days'}], 'secondaryOutcomes': [{'measure': 'Safety will be evaluated by: - Physical exam at screen & then D1 for each cycle - 12 lead ECG & telemetry at screen & Wk 1 to 3 for Schedule 1 & 2, & Wk 1 & 2 (ECG only) for Schedule 3. - Lab tests & AE monitoring throughout the study.', 'timeFrame': '16 Days'}]}, 'conditionsModule': {'keywords': ['Non-Hodgkins Lymphoma', 'Cancer', 'First time in human', 'PLK1 inhibitor', 'Advanced Solid Tumor', 'GSK461364'], 'conditions': ['Lymphoma, Non-Hodgkin']}, 'referencesModule': {'availIpds': [{'id': 'PLK107427', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PLK107427', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PLK107427', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PLK107427', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PLK107427', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PLK107427', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'PLK107427', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '21459796', 'type': 'BACKGROUND', 'citation': 'Olmos D, Barker D, Sharma R, Brunetto AT, Yap TA, Taegtmeyer AB, Barriuso J, Medani H, Degenhardt YY, Allred AJ, Smith DA, Murray SC, Lampkin TA, Dar MM, Wilson R, de Bono JS, Blagden SP. Phase I study of GSK461364, a specific and competitive Polo-like kinase 1 inhibitor, in patients with advanced solid malignancies. Clin Cancer Res. 2011 May 15;17(10):3420-30. doi: 10.1158/1078-0432.CCR-10-2946. Epub 2011 Apr 1.'}], '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/PLK107427?search=study&study_ids=107427#rs', 'label': 'Results for study 107427 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'This is a first time in human study that is being done to determine the maximum tolerated dose and initial pharmacokinetic parameters of GSK461364, given by IV, in adult subjects with solid tumors and Non-Hodgkins lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of advanced solid tumor or Non-Hodgkins Lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory to standard therapies\n* At least 18 years of age\n* Female who are of non-childbearing potential or who have a negative pregnancy test who uses approved contraception\n* Male with a female partner of childbearing potential must have had a vasectomy or both are using approved contraception\n* Lab values that are within range as described in the protocol\n* Paraffin-embedded archival tumor tissue available for testing\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Undergone major surgery or received anti-cancer therapy\n* History of hemolytic anemia\n* Clinical lab tests that are out of range as described in the protocol\n* Females who are pregnant or lactating\n* Significant heart problems\n* Serious or unstable pre-existing medical or psychiatric condition\n* Are not able to comply with the study protocol\n* Use of prohibited medications\n* Have low blood pressure\n* Evidence of symptomatic or untreated central nervous system involvement and require corticosteroids or anti-epileptic meds'}, 'identificationModule': {'nctId': 'NCT00536835', 'briefTitle': 'Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase I Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of [GSK461364], a Polo-like Kinase 1 (PLK1) Inhibitor, in Adult Subjects With Advanced Solid Tumor or Non-Hodgkins Lymphoma', 'orgStudyIdInfo': {'id': 'PLK107427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stage A', 'description': 'Stage A will identify maximum tolerated doses for either Schedule 1 - GSK461364 given once weekly on Day 1, 8 and 15 every 28 days; Schedule 2 - GSK 461364 given twice weekly Days 1, 2, 8, 9, 15 and 16; Schedule 3 Daily on Day 1 to Day 15 every 21 days.', 'interventionNames': ['Drug: GSK461364']}, {'type': 'EXPERIMENTAL', 'label': 'Stage B', 'description': 'Evaluate safety, PK, pharmacodynamic (PD) \\& tumor response in expanded cohorts at the MTD for at least one schedule from Stage A.', 'interventionNames': ['Drug: GSK461364']}], 'interventions': [{'name': 'GSK461364', 'type': 'DRUG', 'description': 'GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs. The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.', 'armGroupLabels': ['Stage A', 'Stage B']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'BT9 7AB', 'city': 'Belfast, Northern Ireland', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'W12 0NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], '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'}}}}