Analysis of Pharmacodynamic Changes Associated With the Administration of the Heat Shock Protein 90 Inhibitor AUY922A in Patients With Advanced Solid Malignancies
Study objectives -
1. Evaluation of HSP70, p-ERK, ERK, p-AKT and AKT in peripheral blood mononuclear cells
(PBMNC). Evaluation of p-AKT and AKT will be done by commercially available Meso Scale
Discovery (MSD) enzyme linked immunosorbent assay (ELISA) kits, while HSP70 will be
studied using ELISA techniques developed within the Institute of Cancer Research.
2. Evaluation of HSP70, p-AKT, AKT, p-ERK, ERK, HER-2 and p-HER2 in tumour tissue.
Evaluation of p-AKT, AKT, p-ERK, ERK, HER-2 and p-HER2 will be done by commercially
available MSD ELISA kits, while HSP70 will be studied using ELISA techniques developed
within the Institute of Cancer Research.
Study design - All patients entering the open label, phase I dose escalation and phase II
expansion arms of AUY922A at the Royal Marsden Hospital will be asked to participate in this
study. Patients will not have to attend additional appointments for this study and samples
will be taken during visits for the planned Phase I/II clinical trial. Consent to donate
samples for this research study is voluntary and patients will be asked to sign a separate
Observational Model: Cohort, Time Perspective: Prospective
These tissues will be utilised to perform pharmacodynamic (PD) assays to demonstrate the evidence of target modulation. Together with pharmacokinetic data, scientific information from these assays will help researchers optimise drug dosing and schedule
Dr Udai Banerji
Institute of Cancer Research, United Kingdom
United Kingdom: Research Ethics Committee