January 2008 U.S & international clinical trial update

By Jim Hughes
LRG Science Team member

The following new United States trials were reported in the December 2007 Newsletter as part of the International Clinical Trial Update. They have now been added to the US table and are repeated here for US readers. All contact information is listed in the clinical trial data sheets below.

XL820 Phase II:

Exelixis has announced this trial as currently open in Park Ridge, IL. Plans are also underway to open at Dana-Farber and at UCLA in 2008. This is a Phase II trial for GIST only.

AUY922 Phase I:

AUY-922 is an HSP-90 inhibitor manufactured by Novartis. Patients may not have had prior HSP-90 or HDAC inhibitor therapy. Novartis study ID is CAUY922A2101.

Perifosine plus Sorafenib Phase I:

Oncology Specialists in Park Ridge, IL has called to inform us they have Phase I Perifosine + Sorafenib. Perifosine is an HDAC inhibitor. Sorafenib inhibits multiple tyrosine kinase targets associated with GIST.

SNX-5422 Phase I:

“Safety and Pharmacology of SNX-5422 Mesylate in Subjects With Refractory Solid Tumor Malignancies” has opened in Nashville, TN and Scottsdale, AZ. SNX-5422 is an HSP-90 inhibitor made by Serenex.

STA-9090 Phase I:

STA-9090 is an HSP-90 inhibitor. According to the Synta press release, in preclinical studies, “STA-9090 has shown the ability to inhibit multiple kinases with comparable potency to, and a broader activity profile than specific kinase inhibitors such as Gleevec, Tarceva and Sutent. In addition, STA-9090 has shown potency ten to 100 times greater than the geldanamycin family of Hsp90 inhibitors, as well as activity against a wider range of kinases. In in vivo models, STA-9090 has shown strong efficacy in a wide range of cancer types, including cancers resistant to Gleevec, Tarceva, and Sutent.” This open-label Phase I study in patients with solid tumors is designed to identify the maximum tolerated dose of STA-9090 based on a twice-a-week intravenous dosing schedule. In addition to an evaluation of safety and tolerability, patients will be assessed for response rate based on the RECIST criteria. A second Phase I study with an alternative, once-a-week dosing schedule is planned.

XL765 Phase I:

Manufacturer Exelixis is sponsoring a Phase I trial of its PI3K and mTOR inhibitor XL765 at two sites in the United States: Wayne State University, Detroit, Mich. and START, San Antonio, TX.

The following additional updates have been made to the US Trial table:

AMN107 Phase III:

H. Lee Moffitt Cancer Center in Tampa, Flor. and MD Anderson in Houston, TX are now open and have been added as sites. Trial number is CAMN107A2201.

IPI504 Phase I:

Mount Sinai Hospital in Toronto, Canada has been added as a site. Martin Blackstein, MD is the Principal Investigator.

Sorafenib (BAY 43-9006) Phase II:

A new site has been added. Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio.

BEZ 235 Phase I:

Now open at the Sarah Cannon Research Institute in Nashville, Tenn. BEZ235 is a Novartis drug that targets the PI3K tyrosine kinase and indirectly inhibits the downstream targets AKT and mTOR. Also available at the Nevada Cancer Institute in Las Vegas.

KOS1022 Phase I:

We were informed in late November that this trial at Colorado University in Aurora, Col. is on hold for toxicity.

To view the latest clinical trials, visit: http://www.liferaftgroup.org/docs/gist_clinical_trial_datasheets.htm