drugset / Trial / NCT01655225

A Study of LY3023414 in Participants With Advanced Cancer

NCT01655225

Phase 1 Completed 156 enrolled Eli Lilly and Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find a recommended dose level and schedule of dosing LY3023414 that can safely be taken by participants with advanced or metastatic cancer. The study will also explore the changes to various markers in blood cells and potentially tumor cells. Finally, the study will help document any antitumor activity this drug may have. In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3023414. In Part B, LY3023414 will be explored in different types of cancer, including breast and lung cancer, lymphoma and mesothelioma.

Timeline

Start
2012-07-31
Primary completion
2019-04-04
Completion
2022-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Midazolam Small molecule 0.2 mg Oral
Subject Samotolisib Small molecule 20 mg Oral
Subject Samotolisib Small molecule 600 mg Oral
Background Abemaciclib Small molecule Oral
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Fulvestrant Small molecule 500 mg Intramuscular
Background Letrozole Other / unclassified Oral
Background Pemetrexed Small molecule 500 mg/m2 Intravenous