A Study of Enzalutamide and LY3023414 in Men With Prostate Cancer

Phase 2 Completed 142 enrolled Eli Lilly and Company Sarah Cannon · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to evaluate the safety and effectiveness of the study drug known as LY3023414 in combination with enzalutamide in men with prostate cancer.

Timeline

Start: 2015-04-29
Primary completion: 2018-09-26
Completion: 2020-04-16

Outcome

Met primary endpoint

paper median PCWG2-PFS and rPFS was significantly longer in the samotolisib/enzalutamide versus placebo/enzalutamide arm (3.8 vs. 2.8 months; P = 0.003 PMID 35363301 ↗

registry Hazard Ratio (HR) 0.5871 (95% CI 0.3967 to 0.8690) NCT02407054 ↗

Publications

Sweeney CJ, Percent IJ, Babu S, Cultrera JL, Mehlhaff BA, Goodman OB, Morris DS, Schnadig ID, Albany C, Shore ND, Sieber PR, Guba SC, Zhang W, Wacheck V, Donoho GP, Szpurka AM, Callies S, Lin BK, Bendell JC. Phase Ib/II Study of Enzalutamide with Samotolisib (LY3023414) or Placebo in Patients with Metastatic Castration-Resistant Prostate Cancer. Clin Cancer Res. 2022 Jun 1;28(11):2237-2247. doi: 10.1158/1078-0432.CCR-21-2326.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Samotolisib	Small molecule	200 mg	Oral
Background	Enzalutamide	Other / unclassified	160 mg	Oral