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Search / Trial NCT01851824

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

Launched by HOFFMANN-LA ROCHE · May 10, 2013

Trial Information

Current as of July 24, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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. participants with radiographically unstable, symptomatic lesions)
  • History of bleeding or coagulation disorders
  • Allergy or hypersensitivity to vemurafenib or acenocoumarol formulations
  • History of malabsorption or other condition that would interfere with the enteral absorption of study treatment
  • Participants with VKORC1 mutations (1639G\→A, 1173C\→T) in either one allele (heterozygous)or two alleles (homozygous)
  • Participants with CYP2C9\*3 mutations in either one allele (heterozygous) or two alleles (homozygous)
  • 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

About Hoffmann La Roche

Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.

Locations

Porto, , Portugal

Barcelona, , Spain

Budapest, , Hungary

Essen, , Germany

Mannheim, , Germany

Amsterdam, , Netherlands

Utrecht, , Netherlands

Thessaloniki, , Greece

Belgrade, , Serbia

Maastricht, , Netherlands

Lisboa, , Portugal

Madrid, , Spain

Buxtehude, , Germany

Crete, , Greece

Auckland, North Island, New Zealand

Christchurch, South Island, New Zealand

Wodonga, New South Wales, Australia

Patients applied

0 patients applied

Trial Officials

Clinical Trials

Study Director

Hoffmann-La Roche

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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