TH-302 is an investigational drug that only becomes active in certain parts of the body — in this case, in cells with low oxygen levels. Cancer cells that are low in oxygen often do not succumb to standard chemotherapy or radiation treatment. TH-302 may be able to kill cancer cells that are low in oxygen without causing too much damage to normal cells with normal oxygen levels.
Doxorubicin is a standard chemotherapy drug used to treat soft-tissue sarcoma. In this study, researchers are comparing doxorubicin plus TH-302 with doxorubicin alone in patients with locally advanced inoperable or metastatic soft-tissue sarcoma. Patients will be randomly assigned to receive doxorubicin plus TH-302 or doxorubicin alone.