Status:
COMPLETED
A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Malignant Melanoma, Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in participants with BR...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01851824
Start Date
August 1 2013
End Date
June 1 2014
Last Update
November 2 2016
Active Locations (20)
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1
Wodonga, New South Wales, Australia, 3690
2
Buxtehude, Germany, 21614
3
Essen, Germany, 45122
4
Mannheim, Germany, 68167