TH-302: Interim Phase I/II data

Data from 12 evaluable patients in the first part of a 3-part, open-label, U.S. Phase I/II trial showed that TH-302 plus dexamethasone led to 2 partial responses, 2 minimal responses and 8 cases of stable disease. Patients received 240, 340 or 480 mg/m 2 plus 40 mg dexamethasone on days 1, 4, 8 and 11 of a 21-day cycle. There were 2 DLTs of grade 3 stomatitis at the 480 mg/m 2 dose. The MTD was 340 mg/m 2. Data were presented at the American Society for Clinical Oncology meeting in Chicago. If >=1 patient achieves a partial response at the MTD in the first part of the trial, then enrollment will continue into the second part, which will evaluate the dose in an additional 15 patients. If data show TH-302 is well tolerated, then the trial will continue onto the third part, which will evaluate escalating doses of TH-302 in combination with Velcade bortezomib. ...