Phase I trial of a new form of an oral administration of VP-16-213.

A new oral form of VP-16-213 consisting of a hydrophilic soft gelatin capsule containing a VP-16-213 solution was tested for toxicity in 26 patients. The drug was administered at four different dose levels, 350, 500, 650, and 750 mg/m2, in 5-day courses every 21-28 days. A dose-dependent effect was observed with regard to hematologic toxicity and alopecia. It is concluded that the drinking ampules of VP-16-213 can be replaced with the new oral capsules with a recommended initial dose of 100-130 mg/m2 given in 5-day courses every 21-28 days.