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A Study of the Effect of Vemurafenib on the Pharmacokinetics of Phenprocoumon in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

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ClinicalTrials.gov Identifier: NCT01849666
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Malignant Melanoma, Neoplasms Drug: phenprocoumon Drug: vemurafenib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: 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
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
Drug Information available for: Vemurafenib

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A: phenprocoumon single dose Drug: phenprocoumon
6 mg oral single dose
Experimental: B: vemurafenib + phenprocoumon single dose Drug: vemurafenib
960 mg bid orally


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849666


Locations
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Belgium
Brussels, Belgium, 1000
Edegem, Belgium, 2650
Gent, Belgium, 9000
Wilrijk, Belgium, 2610
Finland
Helsinki, Finland, 00180
Germany
Heidelberg, Germany, 69120
Mainz, Germany, 55101
Netherlands
Amsterdam, Netherlands, 1066 CX
Maastricht, Netherlands, 6229HX
Utrecht, Netherlands, 3584 CX
Spain
Pamplona, Navarra, Spain, 31008
Barcelona, Spain, 08908
Madrid, Spain, 280146
Madrid, Spain, 28031
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28050
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01849666    
Other Study ID Numbers: GO28398
2012-003707-35 ( EudraCT Number )
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Vemurafenib
Phenprocoumon
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants