Analysis of Pharmacodynamic Changes With AUY922A, an HSP90 Inhibitor

Analysis of Pharmacodynamic Changes Associated With the Administration of the Heat Shock Protein 90 Inhibitor AUY922A in Patients With Advanced Solid Malignancies

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01024283

Enrollment

Registered

2009-12-02

Start date

2008-12-31

Completion date

2013-08-31

Last updated

2009-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Malignancies

Keywords

Heat Shock Protein 90 Inhibitor (HSP90), Pharmacodynamic, Blood, Biopsy, Solid malignancies

Brief summary

The principal research objective of this additional research protocol is to support the collection, storage and use of tumour and surrogate (peripheral blood mononuclear cells - PBMNCs). The objective of this study is to perform assays to study pharmacodynamic (PD) markers that confirm target modulation.

Detailed description

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 consent form.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 consent form.

Exclusion criteria

* Any patient who has not entered the open label phase I dose escalation and phase II expansion arms of AUY922A will not be asked to participate. * Patients with advanced cancers which are not safely biopsiable will not be eligible to participate. * Patients with known coagulation disorders.

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United Kingdom

Contacts

Primary ContactDr Udai Banerji

udai.banerji@icr.ac.uk02086613993

Outcome results