NCT05630989Recruiting

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

Mandana Kamgar, MD

Start Date

2/7/2023

Completion Date

8/1/2027

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).

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Age ≥18 years. 2. Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treating physician 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 to sign it. 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.

Interventions

OTHER

combination therapy with no MEKi

DRUG

combination therapy with MEKi-HCQ

DRUG

combination therapy with MEKi-EGFRi

DRUG

combination therapy with MEKi.

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Conditions

Pancreatic Ductal Adenocarcinoma

Locations

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States