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ARTICLE | Clinical News

Aldoxorubicin: Preliminary Phase III data

August 1, 2016 7:00 AM UTC

Preliminary data from an open-label, international Phase III trial in 433 patients with metastatic, locally advanced or unresectable STS showed that 350 mg/m 2 IV aldoxorubicin on day 1 of each 21-day cycle led to no significant difference in median PFS, the primary endpoint, vs. investigator’s choice of chemotherapy (doxorubicin, ifosfamide, dacarbazine, Votrient pazopanib or gemcitabine plus docetaxel) (4.17 vs. 4.04 months, HR=0.91). Additionally, CytRx said that aldoxorubicin showed a “near doubling” of ORR and disease control rate (DCR) vs. investigator’s choice of chemotherapy. The trial enrolled patients who had either not responded to or who had progressed following treatment with >=1 systemic regimen of non-adjuvant chemotherapy. CytRx has an SPA from FDA for the trial. ...