A dose-finding study has found the investigational agent BIBW 2992 to be well-tolerated in a three-week-on, one-week-off schedule. BIBW 2992 is a highly potent irreversible dual inhibitor of the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER 2).
Forty-three patients with refractory solid tumors have been enrolled in the study. The study's primary endpoints are maximum tolerated dose and toxicity profile of BIBW 2992 when administered for 21 consecutive days every four weeks, and pharmacokinetic parameters after first administration and multiple doses. Secondary endpoints are objective tumor responses and pilot analyses on skin and tumor tissue.
No objective responses have been observed to date; however, 43 percent of 35 evaluable patients have experienced disease stabilization and have been on treatment for three or more months.