Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

Phase 2 Completed 60 enrolled Pfizer Astellas Pharma Inc · collab Medivation LLC, a wholly owned subsidiary of Pfizer Inc. · collab

Parallel-groupOpen-labelTreatment

Summary

This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.

Timeline

Start: 2010-02-18
Primary completion: 2012-02-29
Completion: 2013-08-31

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Enzalutamide, PSA Responders at Week 9 vs Enzalutamide, PSA Non-Responders at Week 9; p = 0.9427; t-test, 2 sided NCT01091103 ↗

registry analysis (superiority or other test); Enzalutamide, PSA Responders at Week 9 vs Enzalutamide, PSA Non-Responders at Week 9; p = 0.3370; t-test, 2 sided NCT01091103 ↗

Publications

Efstathiou E, Titus M, Wen S, Hoang A, Karlou M, Ashe R, Tu SM, Aparicio A, Troncoso P, Mohler J, Logothetis CJ. Molecular characterization of enzalutamide-treated bone metastatic castration-resistant prostate cancer. Eur Urol. 2015 Jan;67(1):53-60. doi: 10.1016/j.eururo.2014.05.005. Epub 2014 May 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	Oral