Ensuring That No One Has To Face GIST Alone — Newsletter of the Life Raft Group — January 2008 —
January 2008 clinical trial update
See TRIALS, Page 9
Phase II Study of Perifosine Plus Gleevec for Patients With GIST
Phase:Conditions:Strategy:NCT#:US Contact:Telephone:US Sites:IIGISTMultiple TargetsNCT00455559Online Collaborative Onc. Groupocogtrials@ocog.net415-946-2410
Cancer Center at Century City
,Los Angeles, CA
, Park Ridge, IL
Kathy Tolzein, RN, 847-268-8200Grand Rapids, MISayre, PA
, Houston, TX800-392-1611
By Jim Hughes
LRG Science Team Member
The following new United States trialswere reported in the December 2007 Newsletter as part of the InternationalClinical Trial Update. They have nowbeen added to the US table and are re- peated here for US readers. All contact information is listed in the table below.
XL820 Phase II:
Exelixis has an-nounced this trial as currently open inPark Ridge, IL. Plans are also underwayto open at Dana-Farber and at UCLA in2008. This is a
Phase II trial for GISTonly
.AUY922 Phase I:
AUY-922 is anHSP-90 inhibitor manufactured by No-vartis. Patients may not have had priorHSP-90 or HDAC inhibitor therapy.Novartis study ID is CAUY922A2101.
Perifosine plus Sorafenib Phase I:
Oncology Specialists in Park Ridge, ILhas called to inform us they have Phase IPerifosine + Sorafenib. Perifosine is anHDAC inhibitor. Sorafenib inhibits mul-tiple tyrosine kinase targets associatedwith GIST.
SNX-5422 Phase I:
“Safety and Phar-macology of SNX-5422 Mesylate inSubjects With Refractory Solid TumorMalignancies” has opened in Nashville,TN and Scottsdale, AZ. SNX-5422 is anHSP-90 inhibitor made by Serenex.
STA-9090 Phase I:
STA-9090 is anHSP-90 inhibitor. According to theSynta press release, in preclinical stud-ies, “STA-9090 has shown the ability toinhibit multiple kinases with comparablepotency to, and a broader activity profilethan specific kinase inhibitors such asGleevec, Tarceva and Sutent. In addi-tion, STA-9090 has shown potency tento 100 times greater than the geldanamy-cin family of Hsp90 inhibitors, as wellas activity against a wider range of kinases. In in vivo models, STA-9090has shown strong efficacy in a widerange of cancer types, including cancersresistant to Gleevec, Tarceva, andSutent.” This open-label Phase I study inpatients with solid tumors is designed toidentify the maximum tolerated dose of STA-9090 based on a twice-a-week in-travenous dosing schedule. In addition toan evaluation of safety and tolerability,patients will be assessed for responserate based on the RECIST criteria. Asecond Phase I study with an alternative,once-a-week dosing schedule is planned.
XL765 Phase I:
Manufacturer Ex-elixis is sponsoring a Phase I trial of itsPI3K and mTOR inhibitor XL765 at twosites in the United States: Wayne StateUniversity, Detroit, Mich. and START,San Antonio, TX.
The following additional updates havebeen made to the US Trial table:
AMN107 Phase III:
H. Lee MoffittCancer Center in Tampa, Flor. and MDAnderson in Houston, TX are now openand have been added as sites. Trial num-ber is CAMN107A2201.
IPI504 Phase I:
Mount Sinai Hospitalin Toronto, Canada has been added as asite. Martin Blackstein, MD is the Prin-cipal Investigator.
Sorafenib (BAY 43-9006) Phase II:
A new site has been added. Arthur G.James Cancer Hospital and Solove Re-search Institute at Ohio State UniversityMedical Center, Columbus, Ohio.
: Now open at theSarah Cannon Research Institute inNashville, Tenn. BEZ235 is a Novartisdrug that targets the PI3K tyrosinekinase and indirectly inhibits the down-stream targets AKT and mTOR. Alsoavailable at the Nevada Cancer Institutein Las Vegas.
KOS1022 Phase I:
We were informedin late November that this trial at Colo-rado University in Aurora, Col. is onhold for toxicity
Imatinib+Pegylated Inter-feron-a 2B
A Phase II Study combining targeted ther-apy with immunotherapy using imatinib +Pegylated Interferon-a 2B in imatinib-naïveGIST patient
Phase:Conditions:Strategy:Study #:US Contact:IIGISTKill GIST Cells,HCI 22172
Univ. of Utah, Salt Lake City, UT
Huntsman Cancer InstituteCandace, 801-581-4477
Study of XL820 given orally to subjectswith solid tumors
Christiaan McEwen, 415-337-1754,firstname.lastname@example.orgOncology Specialists, Park Ridge, ILKathy Tolzein, RN: 847-268-8200
Phase:Conditions:Strategy:NCT#:US Contact:US Sites:
(BAY 43-9006, Nexavar)
Sorafenib in treating malignant GIST patientsthat progressed during or after previous treat-ment with imatinib and sunitinib
Phase:Conditions:Strategy:NCT#:US Contact:Telephone:US Sites:IIGISTMultiple TargetsNCT00265798Univ. Of Chicago Cancer Res. Cent.,Chicago, ILClinical Trials Office, 773-834-7424
City of Hope
, Duarte, CAWarren Chow, MD, 866-434-4673 xt64215
Cancer Care Specialists
, Decatur, IL
James Wade III, MD, 217-876-6617
Onc./Hem. Assoc. of Cent. Il
,Peoria, ILJohn Kugler, MD, 309-243-3605
, Boston, MATravis Quigley, RN: 617-632-5117
, NewYork, NYDavid D’Adamo, MD, 212-639-7573
Ohio State Univ.
, Columbus, OHClinical Trials Office, 614-293-4976