NCT01695005

A Study of LY3039478 in Participants With Advanced Cancer

A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.

Detailed description

In Part A of this study, participants with advanced/metastatic cancer (including lymphoma) will receive increasing doses of LY3039478 to define the dose level for Part B, C, D and E. In Part B, C, D and E LY3039478 will be explored at a predefined fixed dose level. Participants in Part B and D must have a defined alteration in a certain molecular pathway. Enrollment of participants in Part B, C, D and E will start once Part A is completed. In Part F participants will receive increasing doses of LY3039478 in combination with prednisone to define the maximum tolerated dose level.

Conditions

• Neoplasms
• Neoplasm Metastasis
• Lymphoma

Interventions

Type	Name	Description
DRUG	LY3039478	Administered orally
DRUG	Prednisone	Administered orally

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-06-26
• Completion: 2018-06-26
• First posted: 2012-09-27
• Last updated: 2025-12-26
• Results posted: 2025-12-26

Locations

11 sites across 6 countries: United States, Denmark, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study