A Safety Study in Participants With Advanced Solid Tumors

Phase 1 Terminated 234 enrolled Eli Lilly and Company

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine a safe dose of LY573636 (tasisulam) when used in 5 separate combinations with an approved cancer medication for treating participants with advanced cancer. Data from this study will be reviewed for any side effects or anti-tumor activity that may be associated with the LY573636 combination treatments.

Timeline

Start: 2008-07
Primary completion: 2012-10
Completion: 2016-05

Publications

Jotte RM, Von Hoff DD, Braiteh F, Becerra CR, Richards DA, Smith DA, Garbo L, Stephenson J, Conkling PR, Robert-Vizcarrondo F, Chen J, Turner PK, Chow KH, Tai DF, Ilaria R Jr. An innovative, multi-arm, complete phase 1b study of the novel anti-cancer agent tasisulam in patients with advanced solid tumors. Invest New Drugs. 2015 Feb;33(1):148-58. doi: 10.1007/s10637-014-0160-z. Epub 2014 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	60 mg/m2	Intravenous
Subject	Erlotinib	Small molecule	150 mg	Oral
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Tasisulam	Small molecule	—	Intravenous
Subject	Temozolomide	Small molecule	200 mg/m2	Oral

A Safety Study in Participants With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications