Aldoxorubicin: Phase III amended

CytRx said FDA agreed to amend a planned, open-label, international Phase III trial in about 400 patients with metastatic, locally advanced or unresectable STS who have either not responded to or have progressed following treatment with >=1 systemic regimen of non-adjuvant chemotherapy to continue aldoxorubicin dosing until disease progression. The trial, which has a SPA from FDA and is slated to begin this quarter, had planned to evaluate up to 6 cycles of aldoxorubicin.

Last month, CytRx reported additional data from a Phase IIb trial in 123 patients with STS showing that first-line treatment with 350 mg/m 2 IV aldoxorubicin on day 1 of each 21-day cycle met the primary endpoint of improving PFS vs. doxorubicin (see BioCentury, Dec. 16, 2013). The trial enrolled patients with metastatic, locally advanced or unresectable STS who have not been previously treated with chemotherapy. CytRx reported preliminary overall response rate (ORR) data from the trial in October (see BioCentury, Oct. 14, 2013). ...