Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-02 @ 9:11 AM
Study NCT ID:
NCT01765556
Status:
WITHDRAWN
Last Update Posted:
2016-11-02
First Post:
2013-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Bosnia and Herzegovina', 'Brazil', 'Greece', 'Romania', 'Spain', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'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': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007654', 'term': 'Ketoconazole'}, {'id': 'D000077484', 'term': 'Vemurafenib'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2013-01-09', 'studyFirstSubmitQcDate': '2013-01-09', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Area under the concentration time curve', 'timeFrame': 'Approximately 19 days'}, {'measure': 'Pharmacokinetics: Maximum plasma concentration', 'timeFrame': 'Approximately 19 days'}, {'measure': 'Pharmacokinetics: Time to maximum plasma concentration', 'timeFrame': 'Approximately 19 days'}, {'measure': 'Pharmacokinetics: Terminal half-life', 'timeFrame': 'Approximately 19 days'}, {'measure': 'Pharmacokinetics: Apparent clearance', 'timeFrame': 'Approximately 19 days'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence of adverse events', 'timeFrame': 'Approximately 19 days'}]}, 'conditionsModule': {'conditions': ['Malignant Melanoma, Neoplasms']}, 'descriptionModule': {'briefSummary': 'This open-label, multi-center, three-period, one sequence study will investigate the effect of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in Periods B and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 19 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients \\>= 18 years old\n* Patients with either unresectable Stage IIIc or Stage IV metastatic melanoma positive for the BRAFV600 mutation or other malignant tumor type that harbors a V600-activating mutation of BRAF, as determined by results of cobas® 4800 BRAF V600 mutation test or a DNA sequencing method, and who have no acceptable standard treatment options\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Life expectancy \\>= 12 weeks\n* Full recovery from the effects of any major surgery or significant traumatic injury within 14 days prior to the first dose of study treatment\n* Adequate hematologic and end organ function\n* Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two effective methods of contraception\n* Negative serum pregnancy test within 7 days prior to commencement of dosing in women of childbearing potential\n\nExclusion Criteria:\n\n* Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of first dose of study drug\n* Requirement for immediate or urgent treatment with daily vemurafenib and for whom the intermittent schedule of vemurafenib employed during the 19-day period for this trial is not clinically acceptable\n* Allergy or hypersensitivity to components of the vemurafenib formulation\n* Experimental therapy within 4 weeks prior to first dose of study drug\n* Major surgical procedure or significant traumatic injury within 14 days prior to first dose of study drug or anticipation of the need for major surgery during study treatment\n* Prior anti-cancer therapy within 28 days before the first dose of study drug\n* History of clinically significant cardiac or pulmonary dysfunction\n* History of symptomatic congestive heart failure of any New York Heart Association class or serious cardiac arrhythmia requiring treatment\n* History of myocardial infarction within 6 months prior to first dose of study drug\n* Current dyspnea at rest, owing to complications of advanced malignancy or any requirement for supplemental oxygen to perform activities of daily living\n* History of congenital long QT syndrome or QTc \\> 450 ms\n* Active central nervous system lesions\n* Uncontrolled or poorly controlled diabetes\n* Current severe, uncontrolled systemic disease'}, 'identificationModule': {'nctId': 'NCT01765556', 'briefTitle': 'A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With BRAFV600 Mutation-Positive Metastatic Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase I, Open-Label, Multicenter, Three-Period, One-Sequence Study To Investigate The Effect Of Ketoconazole On The Pharmacokinetics Of A Single Oral Dose Of 960 Mg Of Vemurafenib', 'orgStudyIdInfo': {'id': 'GO28054'}, 'secondaryIdInfos': [{'id': '2012-003143-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketoconazole treatment', 'interventionNames': ['Drug: ketoconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Vemurafenib treatment', 'interventionNames': ['Drug: vemurafenib']}], 'interventions': [{'name': 'ketoconazole', 'type': 'DRUG', 'description': 'multiple doses of ketoconazole in Period B and C', 'armGroupLabels': ['Ketoconazole treatment']}, {'name': 'vemurafenib', 'type': 'DRUG', 'description': 'single dose of vemurafenib in Period A and C', 'armGroupLabels': ['Vemurafenib treatment']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}