Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Location status: Recruiting
NCT Number: NCT05630989
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
Milwaukee, Wisconsin, 53226, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This cohort will receive combination therapy with no MEKi.
Other names: mitogen-activated extracellular signal-regulated kinase inhibitor
This cohort will receive combination therapy with MEKi-HCQ.
Other names: mitogen-activated extracellular signal-regulated kinase inhibitor with hydroxychloroquine
This cohort will receive combination therapy with MEKi-EGFRi.
Other names: mitogen-activated extracellular signal-regulated kinase inhibitor with epidermal growth factor receptor inhibitor
This cohort will receive combination therapy with MEKi.
Other names: mitogen-activated extracellular signal-regulated kinase inhibitor
Time frame: 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.
Time frame: 2 years
A complete response will be determined using RECIST v1.1.
Time frame: 2 years
A partial response will be determined using RECIST v1.1.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Mandana Kamgar, MD
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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