A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy

Last updated: April 21, 2025
Sponsor: Mandana Kamgar, MD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatic Cancer

Pancreatic Disorders

Adenocarcinoma

Treatment

combination therapy with no MEKi

combination therapy with MEKi.

combination therapy with MEKi-HCQ

Clinical Study ID

NCT05630989
PRO00045718
  • Ages > 18
  • All Genders

Study Summary

This is an observational precision oncology study designed to collect and analyze data that allows us to characterize the safety and efficacy of several different mitogen-activated protein kinase kinase inhibitor (MEKi) -based treatment strategies and the feasibility of administering MEKi combination therapies to patients with KRAS G12R mutated advanced pancreatic ductal adenocarcinoma (PDAC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years.

  2. Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treatingphysician or tumor board.

  3. Tumor must have KRAS G12R mutation, as determined by a next generation sequencing (NGS) panel or circulating tumor DNA panel of choice of the treating physician.

  4. Ability to understand a written informed consent document and the willingness tosign it.

Exclusion

Exclusion Criteria:

  1. Age <18 years.

  2. Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma

  3. Tumor does not have a KRAS G12R mutation.

Study Design

Total Participants: 80
Treatment Group(s): 4
Primary Treatment: combination therapy with no MEKi
Phase:
Study Start date:
February 07, 2023
Estimated Completion Date:
August 01, 2027

Study Description

Patient medical records, obtained both retrospectively and prospectively, will be examined for results of molecular profiling obtained through standard of care testing to help understand how well KRAS G12R pancreatic patients respond to MEKi-based combination matched therapy. Patient outcome parameters including but not limited to tumor response, patient survival, and toxicity will be analyzed. Moreover, metrics will be collected to ascertain whether a future clinical trial involving a MEKi-based combination therapy is feasible to carry out.

Connect with a study center

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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