Rucaparib Hepatic Impairment Study in Patients with a Solid Tumor
Research type
Research Study
Full title
A Phase 1, Open-Label, Parallel Group Study to Determine the Pharmacokinetics, Safety and Tolerability of Rucaparib in Patients with an Advanced Solid Tumor and either Moderate Hepatic Impairment or Normal Hepatic Function
IRAS ID
234187
Contact name
Yvette Drew
Contact email
Sponsor organisation
Clovis Oncology, Inc
Eudract number
2017-001877-17
Clinicaltrials.gov Identifier
106289, IND Number
Duration of Study in the UK
1 years, 1 months, 11 days
Research summary
This study is evaluating a medication called ‘Rucaparib’ for advanced solid tumours. An advanced solid tumour can be any type of cancer apart from those of the blood or lymphatic system, that has continued to grow despite other treatment, or for which no standard treatment exists.
Rucaparib belongs to a class of anti-cancer agents known as PARP inhibitors. PARP is a protein inside cells that helps repair damage to DNA (genetic material that carries instructions for body growth and development, and allows cells to continue living). Cancer can result when there are faults in DNA that can cause cancer cells to grow out of control. Research has shown that PARP inhibitors stop the PARP protein from working, and sometimes cause cancer cells to stop growing.
The objective of this study is to understand the safety, tolerability, and pharmacokinetic profile of Rucaparib in people with advanced solid tumours who have normal or some abnormal function of their liver. Pharmacokinetics is the way the body absorbs, distributes, and gets rid of a medication and provides information on the amount of study medication in your blood.
Participants will be categorised into two groups according to their liver function. Part I aims to enrol 16 participants for 8 days. Blood and urine samples will be collected for analysis at specific time intervals. After completing Part I, participants will have the option of continuing treatment by rolling over to Part II until further progression of the disease or some other factor that necessitates discontinuation of treatment.
Participants aged 18 years and above will be recruited in up to 10 study sites globally.
Participants will undergo various tests and procedures including blood tests, urine tests, electrocardiograms, X-rays, computed tomography (CT) scans, magnetic resonance imaging (MRI) scans, ultrasound and physical examinations to monitor their disease.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
18/NE/0021
Date of REC Opinion
23 Feb 2018
REC opinion
Further Information Favourable Opinion