Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT01328106
Status:
WITHDRAWN
Last Update Posted:
2017-12-12
First Post:
2010-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000098943', 'term': 'Uveal Melanoma'}], 'ancestors': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D014604', 'term': 'Uveal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C560077', 'term': 'trametinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study was cancelled by the sponsor prior to initiation of study enrollment. No subjects were accrued.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-08', 'studyFirstSubmitDate': '2010-03-18', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate as assessed by RECIST v1.1', 'timeFrame': 'At least 12 weeks after initiating study treatment'}], 'secondaryOutcomes': [{'measure': 'Duration of response, progression free survival, overall survival', 'timeFrame': 'Through study completion or early study discontinuation'}, {'measure': 'Safety, tolerability, and population pharmacokinetic parameters', 'timeFrame': 'Through study completion or early study discontinuation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['GNA11 Mutation-positive Metastatic Melanoma', 'GNAQ Mutation-positive Metastatic Melanoma', 'Cancer', 'Metastatic Uveal Melanoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive GNAQ or GNA11 metastatic melanoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not previously treated with a MEK inhibitor.\n* Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment.\n* The patient has a radiographically measurable tumor.\n* ECOG performance status 0, 1, or 2.\n* The patient is able to swallow and retain oral medication.\n* Life expectancy of at least 4 months.\n* Toxicities from previous anti-cancer therapy (except alopecia) are recovered (Grade 1 or less) at the time of enrollment.\n* The patient has adequate organ and bone marrow function.\n* Sexually active patients must use medically acceptable methods of contraception during the course of the study.\n* Female patients of childbearing potential must have a negative serum pregnancy test at screening.\n\nExclusion Criteria:\n\n* The patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization.\n* The patient has received experimental therapy within 21 days of starting study drug.\n* The patient has received nitrosourea or mitomycin C within 42 days of starting study drug.\n* The patient has received any herbal medications or palliative radiotherapy within 14 days of starting study drug.\n* The patient is currently receiving anticoagulation therapy that is not well controlled.\n* Ongoing or newly diagnosed eye abnormality other than symptoms due to uveal melanoma.\n* History of retinal vein occlusion or central serous retinopathy.\n* Current severe, uncontrolled systemic disease.\n* History of leptomeningeal disease or spinal cord compression secondary to metastasis.\n* Brain metastasis, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery and the disease has been stable for at least 3 months without steroid use or on a stable dose of steroids for at least 1 month prior to starting study drug. Stability of brain metastases must be confirmed with imaging.\n* The patient has a concurrent, active hematological malignancy or other solid tumor malignancy.\n* History of clinically significant cardiac or pulmonary dysfunction.\n* Allergy or hypersensitivity to components of the GSK1120212 formulation.\n* The patient is pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT01328106', 'briefTitle': 'Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects With Uveal Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Single-Arm, Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in Subjects With Metastatic Uveal Melanoma or With Mutation-Positive GNAQ or GNA11 Metastatic Melanoma', 'orgStudyIdInfo': {'id': '114091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: GSK1120212']}], 'interventions': [{'name': 'GSK1120212', 'type': 'DRUG', 'description': 'Repeating oral dose', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}