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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Wisconsin
Froedtert Hospital and the Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Mandana Kamgar, MD, MPH
mkamgar@mcw.edu
414-805-4600
Time Frame
Start Date: 2023-02-07
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 80
Treatments
Therapy with no MEKi
Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors 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. Subjects will receive therapy with no MEKi.
Therapy with MEKi- Hydroxychloroquine (HCQ)
Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors 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. Subjects will receive therapy with MEKi and HCQ.
Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi)
Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors 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. Subjects will receive combination therapy with MEKi and EGFRi.
Therapy with MEKi-Other
Subjects have advanced PDAC with KRAS G12R mutation. Subjects' tumors 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. Subjects will receive combination therapy with MEKi and a specified drug combination.
Related Therapeutic Areas
Sponsors
Leads: Mandana Kamgar, MD

This content was sourced from clinicaltrials.gov

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