NCT04081259

LY3214996 in Patients With AML Who Are Not Candidates for Standard Therapy

A Phase 1 Study of LY3214996, an ERK1/2 Inhibitor, in Patients With AML Who Are Not Candidates for Standard Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating a targeted therapy as a possible treatment for acute myeloid leukemia (AML) that has returned or not responded to standard treatment.

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved LY3214996 as a treatment for any disease. LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor that is being developed as a treatment for patients with advanced cancer. ERK inhibitors stop the signal that a cancer cell receives telling it to grow. In this research study, the investigators are testing to see if LY3214996 is a safe treatment for AML that has returned or not responded to standard treatment. Several doses of the study drug will be explored in this study.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	LY3214996	LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor that is being developed as a treatment for patients with advanced cancer. ERK inhibitors stop the signal that a cancer cell receives telling it to grow.

Timeline

• Start date: 2020-07-15
• Primary completion: 2023-08-03
• Completion: 2023-08-26
• First posted: 2019-09-09
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study