Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma.

ABSTRACT:

Purpose

This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4).

Patients and methods

Patients were randomly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d (1,125-mg loading dose, day 1) or lomustine (100 to 130 mg/m(2), day 1). Assuming a 45% improvement in progression-free survival (PFS), 397 patients were required to provide 80% power to achieve statistical significance at a one-sided level of .025.

Results

Enrollment was terminated at 266 patients (enzastaurin, n = 174; lomustine, n = 92) after a planned interim analysis for futility. Patient characteristics were balanced between arms. Median PFS (1.5 v 1.6 months; hazard ratio [HR] = 1.28; 95% CI, 0.97 to

SUBMITTER: Wick W 

PROVIDER: S-EPMC2834468 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature