Analysis of Pharmacodynamic Changes With AUY922A, an HSP90 Inhibitor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
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

October 30, 2009
December 1, 2009
December 2008
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01024283 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.

Advanced Solid Malignancies
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
August 2013
August 2013   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact: Dr Udai Banerji 02086613993 udai.banerji@icr.ac.uk
United Kingdom
 
NCT01024283
CCR3113
No
Dr Udai Banerji, Institute of Cancer Research
Royal Marsden NHS Foundation Trust
Institute of Cancer Research, United Kingdom
Principal Investigator: Dr Udai Banerji Institute of Cancer Research, United Kingdom
Royal Marsden NHS Foundation Trust
December 2009

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