Phase I studies with bendamustine: an update.

Bendamustine is a novel agent with both alkylating and purine-like moieties that is currently in phase II/III trials for the treatment of hematologic malignancies and breast, lung, and gastrointestinal tumors. Bendamustine was developed in the early 1960s and first used clinically in 1969 in patients with multiple myeloma. Since then, various dose and treatment schedules have been used empirically. Although bendamustine has been in clinical use for over three decades, the early clinical trials do not conform to present-day standards of good clinical practice. Therefore, it was necessary to conduct a full range of clinical trials before application for a European marketing license could be made. To date, bendamustine has been investigated both as a single agent and in combination with other anticancer drugs, in phase I, II, and III clinical trials. This article presents an overview of the recent phase I trials and a summary of ongoing clinical trials.