NCT04870034

Binimetinib and Palbociclib Before Surgery for the Treatment of Operable KRAS-Positive Lung, Colorectal, or Pancreatic Cancer

Perioperative Analysis of Binimetinib and Palbociclib in RAS-Driven Tumors

• Status: Withdrawn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

Summary

This early phase I trial studies the direct effects on cancer cells of the drugs binimetinib and palbociclib, in patients with KRAS-positive lung, colorectal, or pancreatic cancer that can be removed by surgery (operable). Binimetinib and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and palbociclib may halt the growth of cancer cells and improve access of the immune system cells, a patient's own cells that fight infection and cancer, into the tumor.

Detailed description

PRIMARY OBJECTIVE: I. To determine the on-target efficacy of binimetinib and palbociclib in patients with operable RAS-mutant lung adenocarcinoma, colorectal, or pancreatic cancer. SECONDARY OBJECTIVES: I. Correlative analysis of gene expression analysis. II. Define immune subsets within the pre and post-treatment tumor tissue. OUTLINE: Patients receive palbociclib orally (PO) once daily (QD) and binimetinib PO twice daily (BID) for 14 days in the absence of disease progression or unacceptable toxicity. Within 1 week after last dose of study medication, patients undergo surgery. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Colorectal Carcinoma
• Lung Adenocarcinoma
• Malignant Solid Neoplasm
• Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	Binimetinib	Given PO
DRUG	Palbociclib	Given PO
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-09-30
• Completion: 2026-09-30
• First posted: 2021-05-03
• Last updated: 2023-12-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study