BET115521: GSK525762 in Subjects with Solid Tumours
Research type
Research Study
Full title
A phase I/II open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK525762 in subjects with NUT midline carcinoma (NMC) and other cancers.
IRAS ID
180199
Contact name
Johann De Bono
Contact email
Eudract number
2014-004982-25
Clinicaltrials.gov Identifier
IND112942, Investigational New Drug (IND) #
Duration of Study in the UK
10 years, 0 months, 1 days
Research summary
A family of proteins, known as the Bromodomain and extra terminal or BET proteins, have been shown to regulate the expression of a number of genes that are critical for the maintenance of solid tumours. GSK has engineered a drug (GSK525762) that stops the function of these proteins, and switches off the expression of critical cancer-related genes. In extensive preclinical testing, GSK525762 has demonstrated highly promising results, slowing or stopping certain cancer cells from growing in a wide range of solid tumour cancers.
This trial will test how GSK525762 will work in patients with one of the following disease types: Nuclear protein in testis (NUT) midline carcinoma (NMC), small cell lung cancer (SCLC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), castration resistant prostate cancer (CRPC), triple negative breast cancer (TNBC); estrogen receptor positive (ER positive) breast cancer, neuroblastoma (NB), acute leukemias, and other N-Myc driven tumours.
Approximately 60 patients will take part in Part 1 and approximately 150 patients in Part 2, from across the world. Part 1 will look at how people react to and how the body uses GSK525762 at different doses. We want to find out the best dose of GSK525762.Part 2 will be using the best GSK525762 dose to found its effects, good or bad, especially on the heart in people with a wide range of cancers.
Eligible patients (16 years or older) will receive the drug orally and will be extensively monitored to ensure patient safety and assess the side effects and their management. Patients will also be monitored to assess the drugs effect on the tumour. Only when we are satisfied that side effects are minimal, will dose escalation occur, both in existing and newly entered patients. When an optimal dose is identified, a larger number of patients will be treated at this level to determine effects on disease.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1118
Date of REC Opinion
18 Aug 2015
REC opinion
Further Information Favourable Opinion