Spots Global Cancer Trial Database for A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants
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Trial Identification
Brief Title: A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants
Official Title: An Open Label, Phase I Study to Evaluate the Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation Positive Cancer Patients
Study ID: NCT01767623
Conditions
Interventions
Study Description
Brief Summary: This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer. Participants will receive vemurafenib 960 milligrams (mg) (normal hepatic function) or 720 mg (severe hepatic impairment) orally twice daily (BID) on Days 1 to 20 (morning dose) and from Day 27 onward until disease progression or unacceptable toxicity occurs.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
California Cancer Associates for Research & Excellence, Inc., Encinitas, California, United States
Peninsula and South Eastern Haematology and Oncology Grou, Frankston, Victoria, Australia
District General Hospital of Athens Laiko; 1st Internal Medicine Clinic, Athens, , Greece
Rambam Health Care Campus, Haifa, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2, Krasnodar, , Russian Federation
Ege University Medicine Develoment and Pharmacokinetics Research Center; Pulmonary Diseases, Izmir, , Turkey
Velindre Cancer Centre, Cardiff, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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