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Trial Title:
A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy
NCT ID:
NCT05630989
Condition:
Pancreatic Ductal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Hydroxychloroquine
Mitogens
Conditions: Keywords:
Pancreatic Ductal Adenocarcinoma
KRAS G12R mutation
Precision medicine
Retrospective Chart Review
Prospective Chart Review
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Other
Intervention name:
combination therapy with no MEKi
Description:
This cohort will receive combination therapy with no MEKi.
Arm group label:
Therapy with no MEKi
Other name:
mitogen-activated extracellular signal-regulated kinase inhibitor
Intervention type:
Drug
Intervention name:
combination therapy with MEKi-HCQ
Description:
This cohort will receive combination therapy with MEKi-HCQ.
Arm group label:
Therapy with MEKi- Hydroxychloroquine (HCQ)
Other name:
mitogen-activated extracellular signal-regulated kinase inhibitor with hydroxychloroquine
Intervention type:
Drug
Intervention name:
combination therapy with MEKi-EGFRi
Description:
This cohort will receive combination therapy with MEKi-EGFRi.
Arm group label:
Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi)
Other name:
mitogen-activated extracellular signal-regulated kinase inhibitor with epidermal growth factor receptor inhibitor
Intervention type:
Drug
Intervention name:
combination therapy with MEKi.
Description:
This cohort will receive combination therapy with MEKi.
Arm group label:
Therapy with MEKi-Other
Other name:
mitogen-activated extracellular signal-regulated kinase inhibitor
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.
Criteria for eligibility:
Study pop:
Subjects have advanced PDAC with KRAS G12R mutation.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Froedtert Hospital and the Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mandana Kamgar, MD
Phone:
414-805-4600
Email:
mkamgar@mcw.edu
Start date:
February 7, 2023
Completion date:
February 2025
Lead sponsor:
Agency:
Mandana Kamgar, MD
Agency class:
Other
Source:
Medical College of Wisconsin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05630989
