Analysis of Pharmacodynamic Changes With AUY922A, an HSP90 Inhibitor

This study is currently recruiting participants.

Verified December 2009 by Royal Marsden NHS Foundation Trust

Sponsor:

Collaborator:

Institute of Cancer Research, United Kingdom

Information provided by:

Royal Marsden NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01024283

First received: October 30, 2009

Last updated: December 1, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 30, 2009

Last Updated Date

December 1, 2009

Start Date ^ICMJE

December 2008

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01024283 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Analysis of Pharmacodynamic Changes With AUY922A, an HSP90 Inhibitor

Official Title ^ICMJE

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

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.
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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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.

Condition ^ICMJE

Advanced Solid Malignancies

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dr Udai Banerji

02086613993

udai.banerji@icr.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01024283

Other Study ID Numbers ^ICMJE

CCR3113

Has Data Monitoring Committee

Responsible Party

Dr Udai Banerji, Institute of Cancer Research

Study Sponsor ^ICMJE

Royal Marsden NHS Foundation Trust

Collaborators ^ICMJE

Institute of Cancer Research, United Kingdom

Investigators ^ICMJE

Principal Investigator:

Dr Udai Banerji

Institute of Cancer Research, United Kingdom

Information Provided By

Royal Marsden NHS Foundation Trust

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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