GSK525762 in combination with fulvestrant in the treatment of ER+BC
Research type
Research Study
Full title
A phase I/II dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with fulvestrant in subjects with ER+ breast cancer.
IRAS ID
214955
Contact name
Manoj Satyavarapu
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2016-003074-40
Duration of Study in the UK
2 years, 10 months, 23 days
Research summary
Breast cancer is the most common type of cancer in women, affecting an estimated one out of every eight females during their lifetime. Every year nearly 60,000 people are diagnosed with breast cancer in the UK alone.
Treatment with Hormonal agents (treatment with hormones) remains the essential type of treatment for most of these women, followed by cytotoxic chemotherapy (drugs that target cancer cells).Despite advances in the treatment, this disease remains incurable, and relapse (this means the disease returns) is unavoidable.
In this study, GSK (study sponsor) is looking to assess the safety of the study drug, GSK525762 and how well it works when taken with fulvestrant (a drug that is a standard treatment for oestrogen receptor + breast cancer). Participants recruited to this study have advanced oestrogen receptor-positive breast cancer (ER+BC) that hasn’t responded to previous treatment with hormonal agents.
This study consists of 2 parts.
Part 1-
To determine the highest dose of the GSK525762 given in combination with fulvestrant that can be given safely and with the least harmful side effects.
To observe how the body handles the drugs when GSK525762 and fulvestrant are given together and what effect GSK525762 and fulvestrant have on each other in the body.Part 2-
This will start in different participants when Part 1 is completed. The main goal of Part 2 will be to test the safety and effects of GSK525762+fulvestrant when compared to taking fulvestrant alone, in women with ER+BC.The study drug (GSK525762) is not yet approved for doctors to treat patients with ER+BC. Fulvestrant, to be given with GSK525762, is a standard hormonal treatment already used to treat advanced ER+BC.
About 140 women at 40 centers in 8 countries will take part in Part 1 of the study
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0105
Date of REC Opinion
26 Apr 2017
REC opinion
Further Information Favourable Opinion