The enzastaurin glioblastoma phase III trial is a randomized, open label registration study in recurrent glioblastoma multiforme (GBM), which will compare the efficacy, safety and tolerability of enzastaurin, taken orally, with CeeNU, a common oral chemotherapy used to treat this disease.
The study will enroll 397 patients at more than 100 sites worldwide. The primary endpoints of this study will be progression-free survival and overall survival. In this study, Lilly will analyze tissue samples to identify potential biomarkers as a basis for correlating patient response to clinical trial outcomes.
“Through its distinct mechanism of action, preclinical studies suggest that enzastaurin attacks the tumor in multiple ways. While there have been some recent advances in treating this devastating disease, survival rates are still low,” said Dr Richard Gaynor, vice president of cancer research and global oncology platform leader for Lilly.