GSK525762 in CRPC
Research type
Research Study
Full title
A phase IB open-label, dose escalation and expansion study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in combination with androgen deprivation therapy and other agents in subjects with castrate-resistant prostate cancer (CRPC)
IRAS ID
214080
Contact name
Michael Dudley
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2016-003416-13
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
The prostate is a small gland in the pelvis found only in men. Cancer affecting the prostate is the most common cancer in men with around 40 000 cases diagnosed each year in the UK. Most cases develop in men aged 50 or older.
In some cases, treatment is not immediately necessary. The symptoms of prostate cancer appear when the prostate becomes larger and interferes with urination. Prostate cancer can be cured if caught and treated in the early stages of the disease. These treatments include surgery, radiotherapy, and hormonal treatments. If the cancer is caught later and has spread to other parts of the body, it cannot be cured and treatment is then focussed on relieving the symptoms of the disease and prolonging life.
This clinical trial is testing a new drug called GSK525752 as a treatment for prostate cancer that has become resistant to hormone therapy (known as castration-resistant prostate cancer or CRPC). Resistant means that the hormone treatment is no longer stopping the cancer from growing.
In this study, GSK52572 will be given to men along with other drugs that are known to stop prostate cancer from growing. The objective of the study is to see how well the drug works and what side effects are seen. The study will also look at the pharmacokinetics and pharmacodynamics of the drug. Pharmacokinetics investigates how the drug is absorbed and broken down by the body. Pharmacodynamics investigates the effects that the drug has on the body.
This clinical trial is being run in a number of centres in the UK as well as elsewhere in Europe, the USA, and the rest of the world. The Sponsor of the study is GlaxoSmithKline Research & Development Limited. Initially, around 30 patients are expected to be involved in the trial.REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/1054
Date of REC Opinion
20 Jul 2017
REC opinion
Favourable Opinion