BioCentury
ARTICLE | Clinical News

TH-302: Phase III amended

July 15, 2013 7:00 AM UTC

Threshold said FDA approved 2 amendments to its open-label, international Phase III trial comparing 300 mg/m 2 TH-302 on days 1 and 8 of a 21-day cycle plus doxorubicin vs. doxorubicin alone in patients with unresectable STS who have not previously received chemotherapy outside the adjuvant or neoadjuvant setting. Threshold amended the trial to increase enrollment to 620 patients from 450 and remove an interim futility analysis of the PFS secondary endpoint. The company said the increase is intended to adjust for new assumptions about the primary endpoint of OS, noting that patients who receive doxorubicin may live longer than has historically been observed, according to recently published data. Threshold said "given the study's high rate of enrollment, an interim futility analysis would no longer serve its original purpose as the trial would be largely through its enrollment phase by the time the analysis would be completed." The company has an SPA from FDA for the trial. ...