Study Comparing Sotorasib and Panitumumab with Standard Treatments for Colorectal Cancer with KRAS p.G12C Mutation

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05198934

This clinical trial is comparing the effectiveness of a new treatment combination, sotorasib and panitumumab, against standard treatments for patients with colorectal cancer that has a specific KRAS p.G12C mutation. The study aims to see which treatment helps patients live longer without the cancer getting worse.

Patient Parameters

Program Overview

The purpose of this study is to compare how well patients with colorectal cancer that has a KRAS p.G12C mutation respond to a new treatment combination of sotorasib and panitumumab versus standard treatments. The study will look at how long patients live without their cancer progressing when taking either the new treatment or the standard options, which include trifluridine and tipiracil, or regorafenib.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have colorectal cancer that has spread and has a specific KRAS p.G12C mutation, confirmed by a special test.
  • Have received at least one previous treatment for cancer that has spread, and the cancer must have worsened after treatments like fluoropyrimidine, irinotecan, and oxaliplatin, unless these are not suitable for the patient.
  • Have measurable cancer that can be tracked using standard criteria.
  • Be in relatively good health with an ECOG performance status of 0, 1, or 2.
  • Have a life expectancy of more than 3 months.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.5 x 10^9/L.
    • Hemoglobin level of at least 9.0 g/dL.
    • Platelet count of at least 100 x 10^9/L.
    • Liver enzymes and bilirubin levels within specified limits.
    • Normal blood clotting times.
    • Kidney function within specified limits.
  • Have a QTcF interval of 470 milliseconds or less on an ECG.

Exclusion Criteria

  • Have active cancer that has spread to the brain, unless treated and stable.
  • Have had blood cancers unless treated and disease-free for at least 2 years.
  • Have had other cancers in the past 3 years, except for certain non-threatening cancers.
  • Have leptomeningeal disease (cancer spread to the membranes around the brain and spinal cord).
  • Have significant digestive issues that affect medication absorption.
  • Have a history of lung diseases like interstitial pneumonitis or pulmonary fibrosis.
  • Have significant heart disease, recent heart attack, or unstable heart conditions.
  • Have previously been treated with a KRAS G12C inhibitor.

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