NCT03170206

Study of Palbociclib in Combination With Binimetinib for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer

Phase I Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the MEK Inhibitor Binimetinib (MEK162) for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is being conducted as a possible treatment for lung cancer with a specific change in the KRAS gene. The drugs involved in this study are: * Palbociclib * Binimetinib

Detailed description

This research study is a Phase I clinical trial. Participants are being asked to participate in the Phase I portion of the study. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. Palbociclib is an oral drug which has been shown to stop the cell cycle, which is the way a cell initiates growth. Binimetinib is also an oral drug which stops a signal that a cell receives, instructing it to grow. By putting these two drugs together the investigators hope that it will have a greater affect on cancer growth than either drug alone. The FDA (the U.S. Food and Drug Administration) has not approved binimetinib as a treatment for any disease. The FDA has not approved palbociclib for use in lung cancer but it has been approved for other cancer types. The purpose of this study is to: * Test the combination of these two drugs, Palbociclib and Binimetinib, in order to determine a safe and tolerable dose of the combination * Determine the response rate of the combination * Further evaluate the safety and side effect profile for the combination of palbociclib and binimetinib.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Binimetinib	Binimetinib is also an oral drug which stops a signal that a cell receives, instructing it to grow.
DRUG	Palbociclib	It is a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6

Timeline

• Start date: 2017-05-31
• Primary completion: 2023-02-28
• Completion: 2025-12-31
• First posted: 2017-05-30
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study