Phase I study of a FAK inhibitor in subjects with solid tumours
Research type
Research Study
Full title
A Phase I Open-Label Dose-Escalation Study of the Focal Adhesion Kinase Inhibitor, GSK2256098, in Subjects with Solid Tumors
IRAS ID
77217
Contact name
Paul Mulholland
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2010-019644-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This will be a four-part study with a novel compound (GSK2256098) that targets a protein called Focal adhesion kinase (FAK). FAK is over-expressed in a number of tumours and plays a key role in cancer cell survival and their capacity to invade and spread. Part 1, is currently underway elsewhere and aims to determine the maximal dose that can be safely given to cancer patients. Parts 2, 3 and 4 of the study proposed in this application will start after completion of part 1 of the study. In Part 2 of the study, the safety and behaviour of the drug and its activity in a number of tumours that are known to express FAK will be explored. In patients taking part in Part 2 of the study, the maximally tolerated safe dose or a dose lower than the maximal dose will be given. In Part 3, a range of doses below and up to the maximal safe dose will be assessed to see if the same effects occur in the body at lower than the maximal dose. This may potentially allow the drug to be given at doses lower than the maximal safe dose in the future. Patients taking part in part 3 of the study will need to have biopsies of their tumour, skin and hair samples taken during the study as indicators of drug actions, In Part 4, the activity of the drug against brain tumours known as Glioblastoma multiforme (or GBM) that have come back after treatment will be studied, as FAK plays a special role in GBM. All subjects in the study will take the medication by mouth. Subjects will attend regular clinic visits for study-related assessments and remain in the study until tolerating the treatment well or you continue to respond to treatment.
REC name
London - Chelsea Research Ethics Committee
REC reference
11/LO/0551
Date of REC Opinion
6 Jun 2011
REC opinion
Further Information Favourable Opinion