Binimetinib and Palbociclib Before Surgery for the Treatment of Operable KRAS-Positive Lung, Colorectal, or Pancreatic Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Carcinoma
- Lung Adenocarcinoma
- Malignant Solid Neoplasm
- Pancreatic Carcinoma
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04870034
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Christos Fountzilas Roswell Park Cancer Institute
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