Dr. Desai on Phase I Study of Entrectinib in Solid Tumors

Ami Vijay Desai, MD, assistant professor of pediatrics, University of Chicago Comer Children’s Hospital, discusses the design of a phase I study testing entrectinib in patients with solid tumors. She presented these findings at the 2018 ASCO Annual Meeting.

The trial followed a 3+3 dose escalation format and investigated 4 dose levels, Desai says. Researchers were able to escalate to the fourth dose level—at the third level, there was 1 dose-limiting toxicity of increased creatinine for >7 days. At the fourth level, there were 3 dose-limiting toxicities across 2 patients. Desai says these toxicities were reversible on discontinuation of drug.

Phase I data suggest the recommended dose level of entrectinib for pediatric patients is 550 mg/m², according to Desai.