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Doxorubicin will be administered at 50% of its maximum tolerated dose in combination with escalating doses of aldoxorubicin to determine the maximum tolerated dose of the combination of these two drugs in this patient population.
On the basis of these interim results from the Newcastle Phase Ia and Phase Ib studies, the Newcastle investigators concluded that Phase II efficacy studies of five-day infusion of AG337 should be initiated immediately upon determination of the maximum tolerated dose of the drug.
After the maximum tolerated dose is determined, CytRx plans to evaluate the longer-term safety of this dose in a subsequent study to be described at a later time.
Conducted by Kosan and Roche as part of a global partnership to jointly develop and commercialize KOS-862, the Phase I trials were designed to determine the maximum tolerated dose, toxicity profile, pharmacokinetics and pharmacodynamics of intravenous KOS-862.

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