A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients

Phase 2 Completed 108 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.

Timeline

Start: 2007-06
Primary completion: 2009-08
Completion: 2010-06

Outcome

Missed primary endpoint

paper objective response rate between the enzastaurin and placebo arms (placebo: 7 [15.2 %]; enzastaurin: 6 [15.0 %]; P = 1.00 PMID 23435622 ↗

registry p = 1.0000; Median Difference (Final Values) 0.2 (90% CI -12.52 to 12.95) NCT00466440 ↗

Publications

Dreicer R, Garcia J, Rini B, Vogelzang N, Srinivas S, Somer B, Shi P, Kania M, Raghavan D. A randomized, double-blind, placebo-controlled, Phase II study with and without enzastaurin in combination with docetaxel-based chemotherapy in patients with castration-resistant metastatic prostate cancer. Invest New Drugs. 2013 Aug;31(4):1044-50. doi: 10.1007/s10637-013-9940-0. Epub 2013 Feb 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	enzastaurin	Small molecule	500 mg	Oral
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Prednisone	Other / unclassified	5 mg	Oral