NCT04043845

ERK 1/2 Signaling in Ibrutinib Resistant B-cell Malignancies

A Phase 1 Study Targeting ERK 1/2 Signaling in Ibrutinib Resistant B-cell Malignancies

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is studying the safety of combining ibrutinib with the study drug LY3214996 for chronic lymphocytic leukemia (CLL), Waldenstrom's macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL).

Detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational combination of drugs 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. The U.S. Food and Drug Administration (FDA) has approved ibrutinib as a treatment option for this 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 safe when combined with ibrutinib in patients with specific gene mutations. Making treatment decisions based on genetic testing is investigational, and the FDA has not approved this genetic testing. Several doses of LY3214996 will be explored in this study.

Conditions

• Chronic Lymphocytic Leukemia
• Waldenstrom Macroglobulinemia
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib inhibits the function of Bruton's tyrosine kinase (BTK). Ibrutinib blocks signals that stimulate malignant B cells to grow and divide uncontrollably.
DRUG	LY3214996	LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor. ERK inhibitors stop the signal that a cancer cell receives telling it to grow.

Timeline

• Start date: 2020-02-03
• Primary completion: 2020-02-03
• Completion: 2020-02-03
• First posted: 2019-08-02
• Last updated: 2020-02-05

Regulatory

• FDA-regulated drug study