NCT01655225

A Study of LY3023414 in Participants With Advanced Cancer

A Phase 1 First-in-Human Dose Study of LY3023414 in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (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 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.

Conditions

• Advanced Cancer
• Metastatic Cancer
• Non-Hodgkin's Lymphoma
• Metastatic Breast Cancer
• Malignant Mesothelioma
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	LY3023414	Administered orally. Dose of 20 to 600 mg, as determined in Part A.
DRUG	Midazolam	0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.
DRUG	Fulvestrant	500 mg administered IM on Day 1 and Day 15 in cycle 1 and Day 1 every 28 days for additional cycles.
DRUG	Pemetrexed	500 mg/m2 administered IV once on Day 1 every 21 days
DRUG	Cisplatin	75 mg/m2 administered IV once on Day 1 every 21 days
DRUG	Abemaciclib	Administered orally
DRUG	Letrozole	Administered orally

Timeline

• Start date: 2012-07-31
• Primary completion: 2019-04-04
• Completion: 2022-02-02
• First posted: 2012-08-01
• Last updated: 2022-04-08

Locations

8 sites across 3 countries: United States, Italy, Puerto Rico