Analysis of Pharmacodynamic Changes With AUY922A, an HSP90 Inhibitor

Advanced Solid Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01024283
• Other study ID #: CCR3113
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 30, 2009
• Last updated: December 1, 2009
• Start date: December 2008
• Est. completion date: August 2013

Study information

• Verified date: December 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: Dr Udai Banerji
• Phone: 02086613993
• Email: udai.banerji[@]icr.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Solid Malignancies
• Neoplasms

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (2)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No