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

NCT05630989 | Recruiting FDA Drug

• 1 other identifier: PRO00045718
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic Ductal Adenocarcinoma; KRAS G12R mutation; Precision medicine; Retrospective Chart Review; Prospective Chart Review

Outcome Measures

Primary Outcomes (1)

• The number of subjects with no progression.

  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.

  6 months

Secondary Outcomes (4)

• The number of subjects who have a complete response.

  2 years

• The number of subjects who have a partial response.

  2 years

• The number of grade 3 adverse events at least possibly related to a drug.

  2 years

• The number of grade 4 adverse events at least possibly related to a drug.

  2 years

Study Arms (4)

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.

Other: 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.

Drug: 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.

Drug: 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.

Drug: combination therapy with MEKi.

Interventions

combination therapy with no MEKi OTHER

This cohort will receive combination therapy with no MEKi.

Also known as: mitogen-activated extracellular signal-regulated kinase inhibitor

Therapy with no MEKi

combination therapy with MEKi-HCQ DRUG

This cohort will receive combination therapy with MEKi-HCQ.

Also known as: mitogen-activated extracellular signal-regulated kinase inhibitor with hydroxychloroquine

Therapy with MEKi- Hydroxychloroquine (HCQ)

combination therapy with MEKi-EGFRi DRUG

This cohort will receive combination therapy with MEKi-EGFRi.

Also known as: mitogen-activated extracellular signal-regulated kinase inhibitor with epidermal growth factor receptor inhibitor

Therapy with MEKi- Epidermal growth factor receptor inhibitor (EGFRi)

combination therapy with MEKi. DRUG

This cohort will receive combination therapy with MEKi.

Also known as: mitogen-activated extracellular signal-regulated kinase inhibitor

Therapy with MEKi-Other

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects have advanced PDAC with KRAS G12R mutation.

You may qualify if:

• 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.

You may not qualify if:

• Age \<18 years.
• Primary cancer diagnosis other than advanced pancreatic ductal adenocarcinoma
• Tumor does not have a KRAS G12R mutation.

Sponsors & Collaborators

• Mandana Kamgar, MD: lead

Study Sites (1)

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Interventions

Combined Modality Therapy; Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Therapeutics; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Mandana Kamgar, MD, MPH

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mandana Kamgar, MD, MPH

CONTACT

414-805-4600; mkamgar@mcw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: February 7, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)