Belinostat: Interim Phase I/II data
Interim data from 20 STS patients in the Phase II portion of the open-label Phase I/II PXD101-CLN-14 trial showed that 1,000 mg/m 2 belinostat plus 75 mg/m 2 doxorubicin led to a disease control rate (DCR) of 75% at 3 months and an ORR of 15%, including 1 complete response. The combination also produced 12 cases of stable disease (SD). Median duration of disease control was 7.9 months in responders and 5.9 months in patients with SD. The trial met the criteria of >=3 responders to continue enrollment up to 40 STS patients total. The partners previously reported data from the dose-escalation Phase I portion of the trial showing that the recommended dose of 1,000 mg/m 2 belinostat plus 75 mg/m 2 doxorubicin was well tolerated (see BioCentury, Oct.17, 2008). ...