A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy
Mandana Kamgar, MD
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).
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
- Othercombination therapy with no MEKi
This cohort will receive combination therapy with no MEKi.
- Drugcombination therapy with MEKi-HCQ
This cohort will receive combination therapy with MEKi-HCQ.
- Drugcombination therapy with MEKi-EGFRi
This cohort will receive combination therapy with MEKi-EGFRi.
- Drugcombination therapy with MEKi.
This cohort will receive combination therapy with MEKi.
Location
- Froedtert Hospital and the Medical College of WisconsinMilwaukee, Wisconsin