Glivec: Phase II

In an open label international Phase II trial of 532 CML patients who failed therapy with interferon, preliminary results of 388 patients at 3 months showed that Glivec gave a major cytogenetic response rate of 37 percent, including 13 percent complete responses and 23 percent partial responses. Among 290 patients completing 6 months of therapy, 56 percent had major cytogenetic responses. In a separate international Phase II trial of 234 patients with accelerated phase CML, Glivec (given as an initial oral dose of 400 mg/day, increasing to 600 mg/day) gave a 78 percent hematological response rate among 154 patients treated at least 4 weeks, including 22 patients who had a complete response. In that trial, 1 patient died due to liver failure, and a possible interaction between Glivec and acetaminophen was suspected. Other side effects included nausea, vomiting, muscle cramps and headache. ...