A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: combination therapy with no MEKi, combination therapy with MEKi-HCQ, combination therapy with MEKi-EGFRi, combination therapy with MEKi..
- Who it may be relevant to
- Registry conditions: Pancreatic Ductal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other combination therapy with no MEKi
This cohort will receive combination therapy with no MEKi. - Drug combination therapy with MEKi-HCQ
This cohort will receive combination therapy with MEKi-HCQ. - Drug combination therapy with MEKi-EGFRi
This cohort will receive combination therapy with MEKi-EGFRi. - Drug combination therapy with MEKi.
This cohort will receive combination therapy with MEKi.
Primary outcome measures
- The number of subjects with no progression. [Time frame: 6 months]
Secondary outcome measures (4)
- The number of subjects who have a complete response. [Time frame: 2 years]
- The number of subjects who have a partial response. [Time frame: 2 years]
- The number of grade 3 adverse events at least possibly related to a drug. [Time frame: 2 years]
- The number of grade 4 adverse events at least possibly related to a drug. [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Age ≥18 years.
- Diagnosis of advanced pancreatic ductal adenocarcinoma as determined by the treating physician or tumor board.
- 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.
- Ability to understand a written informed consent document and the willingness to sign it.
Exclusion criteria
- Age <18 years.
- Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma
- Tumor does not have a KRAS G12R mutation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Froedtert Hospital and the Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT05630989 · PRO00045718