Phase 1 Program
The goal of the Phase I Program is to perform initial clinical evaluation of promising new anti-cancer compounds emerging from the laboratory. Traditionally, this has been done through trials designed to define dose-limiting toxicities, to identify the maximum tolerated dose that can be used in subsequent Phase II and Phase III testing, and to describe the pharmacokinetic behavior of the compound.
However, the emergence of compounds with non-cytotoxic mechanisms of action -- such as angiogenesis inhibitors, matrix metalloproteinase inhibitors, signal transduction inhibitors, and growth factor inhibitors -- present an entirely new challenge to early clinical evaluation.
Evaluation of these new agents mandates development of new methodologies that allow assessment of surrogate markers and define doses with optimal biologic effect. This will require establishment of new preclinical models, more extensive laboratory-clinical correlative studies, and revision of clinical trial endpoints and design. The Phase I Program has already taken steps to meet these challenges.
- Phase I Referral Form for physicians (PDF format)