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Positive Results Reported for Aldoxorubicin in Sarcoma Patients

Phase II trial shows drug's superiority over doxorubicin (December 11)

Positive efficacy results have been reported from a randomized, open-label phase IIb clinical trial. The study compared the efficacy and safety of aldoxorubicin with that of doxorubicin in patients with first-line metastatic, locally advanced or unresectable soft-tissue sarcoma (STS).

According to the drug’s developer (CytRx Corporation), aldoxorubicin combines the chemotherapeutic agent doxorubicin with a linker molecule that binds specifically to albumin in the blood to allow the delivery of higher amounts of doxorubicin (3.5 to 4 times) without the major dose-limiting toxicities seen with doxorubicin alone.

In the global clinical trial, 123 patients with advanced STS were randomly assigned to receive either aldoxorubicin 350 mg/m2 (n = 83) or doxorubicin 75 mg/m2 (n = 40) every 3 weeks for up to six cycles. The patients were followed every 6 weeks with computed tomography (CT) scans to monitor tumor size. The study’s primary endpoint was progression-free survival (PFS).

Investigators’ assessments and a central laboratory review showed an 80% to 100% improvement in PFS among patients treated with aldoxorubicin compared with doxorubicin. In an intent-to-treat analysis, the investigator-assessed median PFS was 8.4 months for the aldoxorubicin group versus 4.7 months for the doxorubicin group (P = 0.0002), whereas the blinded central laboratory review indicated that the median PFS in patients treated with aldoxorubicin was 5.7 months compared with 2.8 months in patients treated with doxorubicin (P = 0.018).

The overall response rate, as determined by the investigators, was 25.4% for aldoxorubicin-treated patients (2.7% complete response and 22.7% partial response) compared with 5.4% for doxorubicin-treated patients (0% complete response and 5.4% partial response). As assessed by the blinded central laboratory review, 23.0% of aldoxorubicin-treated patients showed a partial response compared with 0% of the doxorubicin-treated patients.

Source: CytRx Corporation; December 11, 2013.

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