TRIAL DETAIL

Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients.

Drug:
Trial Name:
Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients.
NCT#:
Conditions:
Solid Tumors
Status:
Ongoing, but not recruiting
Phase:
1
Start Date 07/15/2007
Age of Trial (yrs) 16.7
Treatment Phase:
Gleevec-resistant
Drug Category:
HSP90 inhibitor
Strategy:
Destroy KIT
Trial Type:
GIST not specified. GIST patients known to be enrolled.
Other Protocol IDs:
CAUY922A2101
Sponsor:
Novartis
Patient Contact:
Novartis Pharmaceuticals 1 800 340-6843
Contact email:
Contact Phone:
Randomized:
IV or Oral:
IV Intravenous
Trial Notes:
AUY922 is a potent Hsp90 inhibitor from Novartis. The phase I portion of this trial allows adults with advanced solid tumors. The trial will then expand into a phase II with expansion arms in patients with either HER2 Positive or ER Positive locally advanced or metastatic breast cancer.
Drug Class: HSP90 inhibitors
Heat Shock Protein 90 (Hsp90) is a protein that has several functions in cells. It is an emerging therapeutic target of interest for the treatment of cancer. Proteins are the mainstay of structural and signaling elements of all cells. Hsp90 is a molecule that maintains the conformation and activity of specific proteins in the cell, also called "client proteins" of Hsp90. KIT is one of the client proteins of Hsp90. Hsp90 enables cancer cell survival by maintaining the function of their mutated client proteins including the KIT and PDGFRA proteins in GIST. Inhibition of Hsp90 therefore has the potential to destroy the activated KIT/PDGFRA proteins resulting in a therapeutic effect in GIST. Since the target of these drugs are Hsp90 and not KIT or PDGFRA, they should be unaffected by the secondary mutations that commonly cause resistance to Gleevec. In fact, preliminary work has suggested that the stronger KIT is activated, the better they work.
Drugs in this class include both oral and intravenous drugs. Some of the intravenous drugs are also being developed as an oral version.

Trial Links

Trial Results

 
 
 

Drug Information

LRG Story about the discovery of Hsp90 inhibitors for GIST.
 
Full text article - NVP-AUY922: a small molecule HSP90 inhibitor with potent antitumor activity in preclinical breast cancer models - Jensen -2008
 
Acquired resistance to 17-allylamino-17-demethoxygeldanamycin (17-AAG, tanespimycin) in glioblastoma cells
 
Full text article - NVP-AUY922: A Novel Heat Shock Protein 90 Inhibitor Active against Xenograft Tumor Growth, Angiogenesis, and Metastasis
 
AACR 2012 - HSP90 inhibitor NVP-AUY922 exhibits the potent antiproliferative effect in gastrointestinal cancer cells with a lack of PTEN expression
 

Trial Sites

Name
Address
City
State
Zip
Country
450 Brookline Ave
Boston
MA
02215-5450
USA
660 S. Euclid Ave
St. Louis
MO
63110
USA
10441 W Twain Ave
Las Vegas
NV
89135
USA
10833 Le Conte Ave
Los Angeles
CA
90095
USA
Augusta
GA
30912
USA
7979 Wurzbach Rd.
San Antonio
TX
78229
USA
1505 Holcombe Blvd.
Houston
TX
77030
USA
Bellinzona
Switzerland
London
SM2 5TP
UK