Phase I/IIa FTIH study of GSK2636771 in PTEN- solid tumour patients
Research type
Research Study
Full title
A Phase I/IIa, First Time in Human, open-label dose-escalation study of GSK2636771 in subjects with advanced solid tumors with PTEN deficiency.
IRAS ID
93490
Contact name
Johann De-Bono
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2011-003778-94
Clinicaltrials.gov Identifier
Research summary
This is a first time in human trial to evaluate the use of GSK2636771 as a novel, oral anti-cancer agent. GSK2636771 acts as a selective inhibitor of a protein called PI3K-beta, that has been implicated in the abnormal growth of cells with a deficiency of the tumour suppressor gene (genes that prevent cancer cells from growing) called PTEN. Due to the deficiency or loss of PTEN, there is reduced control over the activity of PI3K-beta and in turn, this leads to an increased growth of these cells. The primary aim of this study is to determine the safety, tolerability, and how the body handles GSK2636771 over a period of time (pharmacokinetic profile). The secondary aim of the study is to evaluate the effect of GSK2636771 on the body (pharmacodynamics), explore clinical tumour response to GSK2636771, and to define safe and well-tolerated doses of GSK2636771 that can be used in future research. The study will be conducted in 3 parts:Part 1 - Initial dose selection: To select a dose that will give the body enough exposure to GSK2636771. The selected dose will be the starting dose in part 2. Part 2 - Dose escalation: Doses of GSK2636771 will be given to patients in groups of 3 to 6, if no significant side effects are seen, the dose will continue to be increased until the highest safest dose and/or a highest dose that has an effect on the cancer is achieved. This dose will be defined as the recommended phase 2 dose or the maximum tolerated dose. Part 3 - Dose expansion in specific cancer types: The sub-group of patients enrolled will be administered the recommended dose of GSK2636771, and clinical efficacy of GSK2636771 will be measured.
REC name
London - Central Research Ethics Committee
REC reference
12/LO/0313
Date of REC Opinion
8 Mar 2012
REC opinion
Favourable Opinion