December 2007 U.S & international clinical trial update
By Jim Hughes
LRG Science Team member
US Trials
AUY922 Phase I:
A phase I dose escalation study of AUY922 administered intravenously on a once weekly schedule in adult patients with advanced solid malignancies. AUY-922 is an HSP-90 inhibitor manufactured by Novartis. Patients may not have had prior HSP-90 or HDAC inhibitor therapy. Locations include UCLA, contact: Carolyn Britten, M.D. 310-825-5268; Dana Farber contact: Stephen Hodi, M.D. 617-632-5053; Washington University (St. Louis, MO) contact: Paula Fracasso, M.D. 314-362- 5654; Nevada Cancer Institute (Las Vegas, NV) contact: Sunil Sharma, M.D. 702-822-5360. Novartis also lists a central contact number 1-800-340-6843. Novartis study ID is CAUY922A2101 and the NCT is NCT00526045.
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. Patient contact Kathy Tolzein, RN, 847-268-8200. NCT is NCT00398814.
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 imatinib, erlotinib, and sunitinib. 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 1 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 1 study with an alternative, once-a-week dosing schedule is planned. Contact Jeffrey Shapiro, MD, PhD at Dana-Farber: (617) 632-4942.
SNX-5422 Phase I:
“Safety and pharmacology of SNX-5422 mesylate in subjects with fefractory solid tumor malignancies” has opened in Nashville, TN and Scottsdale, AZ. SNX-5422 is an HSP-90 inhibitor made by Serenex. Contact: Trisha L. Hoyle, B.A. 919-792- 3740. NCT is NCT00506805.
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 Univ., Detroit, MI, contact Theresa Laeder 313-576-9386 and START, San Antonio, TX, contact: Gina Mangold, 210- 413-3594. NCT is NCT00485719.
International Trials
AB1010 Phase II:
The AB1010 Phase II trial in France is closed. Results were presented at the American Society of Clinical Oncology in June. Preliminary reports are that 90 percent of untreated GIST patients had benefit. Plans are underway for two first and second line randomized trials.
Imatinib + RAD001 Phase II:
There are 11 clinics in Germany where the trial is listed as open. Contact information is available at the Novartis web site in Germany www.novartis.de. Locations and contact information are listed after selection of a postal code area. Novartis also supplied a telephone number in Basel: 41 61 324 111.
PTK787:
This trial is now listed as closed.
XL765 Phase I:
Manufacturer Exelixis is sponsoring a Phase I trial in cancer of its oral PI3K and mTOR inhibitor XL765 at Hospital Universitario Vall d'Hebron Barcelona, Spain. A thirty day drug holiday may be required prior to trial start.
To view the latest clinical trials, visit: http://www.liferaftgroup.org/docs/gist_clinical_trial_datasheets.htm
