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news.Expects to report data from the ongoing phase 1 and phase 1/2 trials in the first half of 2010
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Synta Pharmaceuticals (Synta) has initiated phase 2 clinical study of STA-9090 in patients with advanced gastrointestinal stromal tumors (GIST). This is the sixth clinical study of STA-9090, a potent, synthetic, small molecule Hsp90 inhibitor with a novel chemical structure.
Synta expects to report data from the ongoing phase 1 and phase 1/2 trials and initiate studies in multiple other cancer indications in the first half of 2010.
The non-randomised, open-label, multi-center phase 2 study is designed to characterise the efficacy and safety of STA-9090 in patients with metastatic or unresectable GIST, following failure of systemic treatment with imatinib (Gleevec) and sunitinib (Sutent).
Reportedly, the trial is expected to enroll up to approximately 55 patients in a two-stage design. Patients will be stratified according to whether or not they have been exposed to other Hsp90 inhibitors, and STA-9090 will be administered as a single agent on a once-weekly intravenous dosing schedule.
In the study, patients tolerating STA-9090 may continue on treatment until disease progression. Patients will be assessed for clinical benefit rate per RECIST criteria. Other objectives of the trial are to assess the impact of treatment with STA-9090 on certain biomarkers and to characterize the safety of STA-9090 in this patient population.
Vojo Vukovic, senior vice president and chief medical officer of Synta, said: “We and our collaborators have been encouraged by the positive preclinical results for STA-9090 in GIST as well as early clinical results from our solid tumor Phase 1 trials, where STA-9090 has generated objective tumor responses and has been well-tolerated.
“A particularly encouraging observation was that a GIST patient on our once- weekly dosing Phase 1 solid tumor study, who experienced disease progression while on multiple prior therapies, including Gleevec and Sutent, experienced substantial tumor shrinkage and stabilization of disease following treatment with STA-9090. We are looking forward to working closely with leading GIST investigators to evaluate the potential of STA-9090 to benefit patients with this disease.”