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A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants

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

NCT01767623•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed BRAF V600 mutation-positive advanced solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
•Normal or impaired hepatic function (hepatic function will be classified according to the NCI Organ Dysfunction Working Group criteria)
•For participants with hepatic impairment: Stable hepatic function for at least 2 weeks (greater than \[\>\] 14 days) before Day 1
•Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (\</=) 2
•Participants with a history of recent brain metastases must have completed any radiation therapy at least 4 weeks before Day 1, be without intervening signs of brain lesion progression and not require steroids before starting the protocol (Day 1). Participants with gliomas or known brain metastases who require anticonvulsants must be seizure free for 1 month prior to enrollment
•Life expectancy greater than or eual to (\>/=) 8 weeks
•Adequate hematologic and renal function
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (\<) 1 percent per year during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria

•Allergy or hypersensitivity to components of the vemurafenib formulation
•Requirement for immediate or urgent treatment with twice a day vemurafenib and for whom the intermittent schedule of vemurafenib employed during Days 1-26 of this trial is not clinically acceptable
•Chemotherapy, biologic therapy, immunotherapy, or radiotherapy within 4 weeks prior to entering the study, or those who have not recovered from AEs because of agents administered more than 4 weeks earlier
•Gliomas or known brain metastases that require corticosteroids
•History of clinically significant cardiac or pulmonary dysfunction
•Human Immunodeficiency Virus (HIV)-positive participant requiring antiviral treatment including protease inhibitors
•Active infection or chronic infection requiring chronic suppressive antibiotics
•Pregnancy or breastfeeding at Day 1
•History of malabsorption or other clinically significant metabolic dysfunction
•Active autoimmune disease
+1 more criteria

Locations (8)

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, Russia

Ege University Medicine Develoment and Pharmacokinetics Research Center; Pulmonary Diseases

Izmir, Turkey (Türkiye)

Velindre Cancer Centre

Cardiff, United Kingdom

Key Dates

Start Date

August 20, 2013

Primary Completion Date

April 20, 2017

Completion Date

April 20, 2017

Last Updated

February 13, 2018

Enrollment

ACTUAL participants

Conditions

Neoplasms

Interventions

Vemurafenib

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants

Inclusion Criteria

Exclusion Criteria

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