PK study of Carfilzomib in Patients with Hepatic Impairment
Research type
Research Study
Full title
An Open-Label, Single Arm, Phase 1 Study of the Pharmacokinetics and Safety of Carfilzomib in Subjects with Advanced Malignancies and Varying Degrees of Hepatic Impairment
IRAS ID
136226
Contact name
Elizabeth Ruth Plummer
Contact email
Sponsor organisation
Onyx Theraputics Inc.
Eudract number
2013-001820-21
ISRCTN Number
N/A
Research summary
The purpose of this study is to see how an investigational drug called Carfilzomib effects the body of a patient and their cancer. This study is being carried out in patients who have an advanced malignancy with varying degrees of liver function to see if they respond differently to the study drug. Results of this study will provide evidence for dose adjustments in patients with varying degrees of liver function impairment. Eligible patients will have relapsed or progressive cancer (either a solid tumour or a haematological malignancy) and have had at least 2 prior treatments before starting this study. The patients will be put into groups, or cohorts, depending on how impaired their liver function is. They will be treated at one of 3 hospital sites in the UK. The study is also being carried out in North America, Australia and other EU countries. Patients can be treated for as long as they are receiving benefit and will be assessed for safety and for any response in the cancer. Patients will be treated on days 1, 2, 8, 9, 15 and 16 of a 4 week cycle. The study drug is given through a vein in the arm over a 30 minute period. Blood samples will be taken at time points before, during and after the treatment. These blood samples will measure the amount of drug in the body. These samples will be taken on day 16 of the first cycle and day 1 of the 2nd cycle. Blood samples will also be taken for routine safety assessments. The cycles of treatment will be repeated whilst the patient is receiving benefit or until their disease worsens.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
13/NE/0293
Date of REC Opinion
18 Nov 2013
REC opinion
Further Information Favourable Opinion