Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-02-18 @ 2:45 PM
Study NCT ID:
NCT01849666
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2013-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil']}, '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': 'D010644', 'term': 'Phenprocoumon'}, {'id': 'D000077484', 'term': 'Vemurafenib'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2013-05-03', 'studyFirstSubmitQcDate': '2013-05-03', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Area under the concentration-time curve (AUC)', 'timeFrame': 'Pre-dose and up to 168 hours post-dose'}, {'measure': 'Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Maximum plasma concentration (Cmax)', 'timeFrame': 'Pre-dose and up to 168 hours post-dose'}, {'measure': 'Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Time to maximum plasma concentration (Tmax)', 'timeFrame': 'Pre-dose and up to 168 hours post-dose'}, {'measure': 'Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Terminal half-life (t1/2)', 'timeFrame': 'Pre-dose and up to 168 hours post-dose'}, {'measure': 'Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Apparent clearance (CL/F)', 'timeFrame': 'Pre-dose and up to 168 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Safety: Incidence, nature and severity of adverse events (AEs) and serious AEs, graded according to NCI CTCAE Version 4.0', 'timeFrame': 'approximately 1.5 years'}]}, 'conditionsModule': {'conditions': ['Malignant Melanoma, Neoplasms']}, 'descriptionModule': {'briefSummary': 'This open-label, multicenter, parallel study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of phenprocoumon in patients with BRAFV600 mutation-positive metastatic malignancies. Patients will be randomized to receive either treatment A: a single oral dose of phenprocoumon 6 mg on Day 1 (Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764).), or treatment B: vemurafenib 960 mg orally twice daily on Days 1-29 plus a single oral dose of phenprocoumon 6 mg on Day 22 (with the option to receive vemurafenib in the extension study after completion of pharmacokinetic assessments).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, 18-70 years of age\n* Patients with either unresectable Stage IIIc or IV BRAFV600 mutation-positive metastatic melanoma or other malignant BRAFV600 mutation-positive tumor type and who have no acceptable standard treatment options\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n* Full recovery from any major surgery or significant traumatic injury at least 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 female partners of childbearing potential must agree to use 2 effective methods of contraception as defined by protocol during the course of the study and for at least 6 months after completion of study treatment\n\nExclusion Criteria:\n\n* Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1\n* Prior anti-cancer therapy within 28 days (6 weeks for nitrosureas or mitocyn C, or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study treatment Day 1\n* Palliative radiotherapy within 2 weeks prior to first dose of study treatment Day 1\n* Experimental therapy within 4 weeks prior to first dose of study treatment Day 1\n* History of clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade \\>/=2 hypertension or unstable angina\n* Current Grade \\>/=2 dyspnea or hypoxia or need for oxygen supplementation\n* History of myocardial infarction within 6 months prior to first dose of study treatment\n* Active central nervous system lesions (i.e. patients with radiographically unstable, symptomatic lesions)\n* History of bleeding or coagulation disorders\n* Allergy or hypersensitivity to vemurafenib or phenprocoumon formulations\n* History of malabsorption or other condition that would interfere with the enteral absorption of study treatment\n* History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or active hepatitis B or hepatitis C virus infection\n* Human immunodeficiency virus (HIV) infection requiring antiretroviral treatment, or AIDS-related illness\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01849666', 'briefTitle': 'A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A PHASE I, OPEN-LABEL, MULTICENTER, RANDOMINZED, PARALELL STUDY TO INVESTIGATE THE EFFECT OF VEMURAFENIB ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF PHENPROCOUMON IN PATIENTS WITH BRAFV600 MUTATION-POSITIVE METASTATIC MALIGNANCY', 'orgStudyIdInfo': {'id': 'GO28398'}, 'secondaryIdInfos': [{'id': '2012-003707-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A: phenprocoumon single dose', 'interventionNames': ['Drug: phenprocoumon']}, {'type': 'EXPERIMENTAL', 'label': 'B: vemurafenib + phenprocoumon single dose', 'interventionNames': ['Drug: vemurafenib']}], 'interventions': [{'name': 'phenprocoumon', 'type': 'DRUG', 'description': '6 mg oral single dose', 'armGroupLabels': ['A: phenprocoumon single dose']}, {'name': 'vemurafenib', 'type': 'DRUG', 'description': '960 mg bid orally', 'armGroupLabels': ['B: vemurafenib + phenprocoumon single dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '00180', 'city': 'Helsinki', 'country': 'Finland', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '55101', 'city': 'Mainz', 'country': 'Germany', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '1066 CX', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6229HX', 'city': 'Maastricht', 'country': 'Netherlands', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '08908', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '280146', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28031', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}