- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01849666
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
November 1, 2016 updated by: Hoffmann-La Roche
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium, 1000
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Edegem, Belgium, 2650
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Gent, Belgium, 9000
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Wilrijk, Belgium, 2610
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Helsinki, Finland, 00180
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Heidelberg, Germany, 69120
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Mainz, Germany, 55101
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Amsterdam, Netherlands, 1066 CX
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Maastricht, Netherlands, 6229HX
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Utrecht, Netherlands, 3584 CX
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Barcelona, Spain, 08908
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Madrid, Spain, 28040
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Madrid, Spain, 28041
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Madrid, Spain, 28050
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Madrid, Spain, 28031
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Madrid, Spain, 280146
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Navarra
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Pamplona, Navarra, Spain, 31008
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients, 18-70 years of age
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Full recovery from any major surgery or significant traumatic injury at least 14 days prior to the first dose of study treatment
- Adequate hematologic and end organ function
- 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
Exclusion Criteria:
- Prior treatment with vemurafenib or other BRAF inhibitor within 42 days of Day 1
- 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
- Palliative radiotherapy within 2 weeks prior to first dose of study treatment Day 1
- Experimental therapy within 4 weeks prior to first dose of study treatment Day 1
- History of clinically significant cardiac or pulmonary dysfunction, including current uncontrolled Grade >/=2 hypertension or unstable angina
- Current Grade >/=2 dyspnea or hypoxia or need for oxygen supplementation
- History of myocardial infarction within 6 months prior to first dose of study treatment
- Active central nervous system lesions (i.e. patients with radiographically unstable, symptomatic lesions)
- History of bleeding or coagulation disorders
- Allergy or hypersensitivity to vemurafenib or phenprocoumon formulations
- History of malabsorption or other condition that would interfere with the enteral absorption of study treatment
- History of clinically significant liver disease (including cirrhosis), current alcohol abuse, or active hepatitis B or hepatitis C virus infection
- Human immunodeficiency virus (HIV) infection requiring antiretroviral treatment, or AIDS-related illness
- Pregnant or lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: A: phenprocoumon single dose
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6 mg oral single dose
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Experimental: B: vemurafenib + phenprocoumon single dose
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960 mg bid orally
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Area under the concentration-time curve (AUC)
Time Frame: Pre-dose and up to 168 hours post-dose
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Pre-dose and up to 168 hours post-dose
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Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Maximum plasma concentration (Cmax)
Time Frame: Pre-dose and up to 168 hours post-dose
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Pre-dose and up to 168 hours post-dose
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Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Time to maximum plasma concentration (Tmax)
Time Frame: Pre-dose and up to 168 hours post-dose
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Pre-dose and up to 168 hours post-dose
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Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Terminal half-life (t1/2)
Time Frame: Pre-dose and up to 168 hours post-dose
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Pre-dose and up to 168 hours post-dose
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Pharmacokinetics of single-dose phenprocoumon under conditions of vemurafenib steady-state exposure: Apparent clearance (CL/F)
Time Frame: Pre-dose and up to 168 hours post-dose
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Pre-dose and up to 168 hours post-dose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Safety: Incidence, nature and severity of adverse events (AEs) and serious AEs, graded according to NCI CTCAE Version 4.0
Time Frame: approximately 1.5 years
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approximately 1.5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
May 3, 2013
First Submitted That Met QC Criteria
May 3, 2013
First Posted (Estimate)
May 8, 2013
Study Record Updates
Last Update Posted (Estimate)
November 2, 2016
Last Update Submitted That Met QC Criteria
November 1, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Anticoagulants
- Phenprocoumon
- Vemurafenib
Other Study ID Numbers
- GO28398
- 2012-003707-35 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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