Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Pancreatic Ductal Adenocarcinoma, KRAS G12R mutation, Precision medicine, Retrospective Chart Review, Prospective Chart Review
Brief 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.
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.
Sponsors
Mandana Kamgar, MD
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects with no progression. | 6 months | This is defined as the time from the start of treatment until six months on treatment, or disease progression, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of subjects who have a complete response. | 2 years | A complete response will be determined using RECIST v1.1. |
| The number of subjects who have a partial response. | 2 years | A partial response will be determined using RECIST v1.1. |
| The number of grade 3 adverse events at least possibly related to a drug. | 2 years | Adverse events and serious adverse events will be classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. |
| The number of grade 4 adverse events at least possibly related to a drug. | 2 years | Adverse events and serious adverse events will be classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5. |
Countries
United States
Contacts
CONTACTMandana Kamgar, MD, MPH
PRINCIPAL_INVESTIGATORMandana Kamgar, MD, MPH
Medical College of Wisconsin
Outcome results
None listed