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

Malignant Solid Neoplasm Clinical Trial

Official title:
Perioperative Analysis of Binimetinib and Palbociclib in RAS-Driven Tumors

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04870034
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Withdrawn
Phase Early Phase 1
Start date January 15, 2024
Completion date September 30, 2026
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