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

NCT ID: NCT05630989

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2027-08-01

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

combination therapy with no MEKi

Intervention Type: OTHER

This cohort will receive combination 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.

combination therapy with MEKi-HCQ

Intervention Type: DRUG

This cohort will receive combination therapy with MEKi-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.

combination therapy with MEKi-EGFRi

Intervention Type: DRUG

This cohort will receive combination therapy with MEKi-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.

combination therapy with MEKi.

Intervention Type: DRUG

This cohort will receive combination therapy with MEKi.

Interventions

combination therapy with no MEKi

This cohort will receive combination therapy with no MEKi.

Intervention Type: OTHER

combination therapy with MEKi-HCQ

This cohort will receive combination therapy with MEKi-HCQ.

Intervention Type: DRUG

combination therapy with MEKi-EGFRi

This cohort will receive combination therapy with MEKi-EGFRi.

Intervention Type: DRUG

combination therapy with MEKi.

This cohort will receive combination therapy with MEKi.

Intervention Type: DRUG

Other Intervention Names

mitogen-activated extracellular signal-regulated kinase inhibitor; mitogen-activated extracellular signal-regulated kinase inhibitor with hydroxychloroquine; mitogen-activated extracellular signal-regulated kinase inhibitor with epidermal growth factor receptor inhibitor; mitogen-activated extracellular signal-regulated kinase inhibitor

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mandana Kamgar, MD

OTHER

Sponsor Role: lead

Responsible Party

Mandana Kamgar, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mandana Kamgar, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mandana Kamgar, MD, MPH

Role: CONTACT

mkamgar@mcw.edu

414-805-4600

Facility Contacts

Mandana Kamgar, MD

Role: primary

mkamgar@mcw.edu

414-805-4600

Other Identifiers

PRO00045718

Identifier Type: -

Identifier Source: org_study_id