NCT05630989

A Registry to Capture Patient Outcomes With KRAS G12R Altered Advanced Pancreatic Ductal Adenocarcinoma Treated With MEK Inhibitor-based Combination Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Mandana Kamgar, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-02-07
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2022-11-30
• Last updated: 2025-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study