Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase 1/2, Multicenter, Dose-Escalation Study to Determine the Safety, Efficacy and Pharmacokinetics of TH-302 in Combination With Doxorubicin in Patients With Advanced Soft Tissue Sarcoma
The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Advanced Soft Tissue Sarcoma.
A broad range of tumors have been shown to contain significant numbers of hypoxic cells and
hypoxia has been shown to be associated with a poor prognosis and an increase in resistance
to chemotherapy and radiotherapy (Brizel 1997, Vaupel 2007, Shannon 2003).
It is likely that an agent that could effectively target hypoxic regions in tumors would
improve efficacy when combined with standard chemotherapy or radiotherapy. TH-302 is
activated at lower oxygen concentrations than other bioreductive prodrugs (Duan 2008) and
tirapazamine, a hypoxic cytotoxin that has been extensively studied in both preclinical and
clinical studies. This should result in an improved therapeutic ratio (tumor vs normal tissue
toxicity) as compared with other bioreductive agents. Because TH-302 is expected to be
minimally toxic to aerobic cancer cells, optimal efficacy would be expected when TH-302 is
combined with treatments that are most effective under aerobic conditions such as
radiotherapy and cytotoxic chemotherapy. Preclinical data have shown at least additive
efficacy when TH-302 is combined with chemotherapy. In order to minimize the risk of additive
toxicity, TH-302 is not being evaluated in combination with alkylating agents. The study will
enroll subjects with advanced soft tissue sarcoma. These tumors have evidence supporting the
presence of hypoxia based on pO2 histography, F-MISO and gene expression profiling (Vaupel
2007, Francis 2007, Rajendran 2003).
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