Analysis of Pharmacodynamic Changes With AUY922A, an HSP90 Inhibitor
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|ClinicalTrials.gov Identifier: NCT01024283|
Recruitment Status : Unknown
Verified December 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : December 2, 2009
Last Update Posted : December 2, 2009
|Condition or disease||Phase|
|Advanced Solid Malignancies||Phase 1 Phase 2|
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 :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Analysis of Pharmacodynamic Changes Associated With the Administration of the Heat Shock Protein 90 Inhibitor AUY922A in Patients With Advanced Solid Malignancies|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024283
|Contact: Dr Udai Banerjifirstname.lastname@example.org|
|Royal Marsden NHS Foundation Trust||Recruiting|
|Sutton, Surrey, United Kingdom, SM2 5PT|
|Principal Investigator:||Dr Udai Banerji||Institute of Cancer Research, United Kingdom|