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NCT Number: NCT05630989

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Mandana Kamgar, MD

CONTACT

[email protected]

414-805-4600

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

combination therapy with no MEKi

Other

This cohort will receive combination therapy with no MEKi.

Other names: mitogen-activated extracellular signal-regulated kinase inhibitor

combination therapy with MEKi-HCQ

Drug

This cohort will receive combination therapy with MEKi-HCQ.

Other names: mitogen-activated extracellular signal-regulated kinase inhibitor with hydroxychloroquine

combination therapy with MEKi-EGFRi

Drug

This cohort will receive combination therapy with MEKi-EGFRi.

Other names: mitogen-activated extracellular signal-regulated kinase inhibitor with epidermal growth factor receptor inhibitor

combination therapy with MEKi.

Drug

This cohort will receive combination therapy with MEKi.

Other names: mitogen-activated extracellular signal-regulated kinase inhibitor

Primary outcomes

  1. The number of subjects with no progression.

    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.

Secondary outcomes

  1. The number of subjects who have a complete response.

    Time frame: 2 years

    A complete response will be determined using RECIST v1.1.

  2. The number of subjects who have a partial response.

    Time frame: 2 years

    A partial response will be determined using RECIST v1.1.

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

    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.

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mandana Kamgar, MD, MPH

CONTACT

[email protected]

414-805-4600

Sponsors and collaborators

Lead sponsor

Mandana Kamgar, MD

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 30, 2022
Registry last updated
May 5, 2026

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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