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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Mandana Kamgar, MD
Study ID
NCT05630989
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • combination therapy with no MEKi — OTHER
    This cohort will receive combination therapy with no MEKi.
  • combination therapy with MEKi-HCQ — DRUG
    This cohort will receive combination therapy with MEKi-HCQ.
  • combination therapy with MEKi-EGFRi — DRUG
    This cohort will receive combination therapy with MEKi-EGFRi.
  • combination therapy with MEKi. — DRUG
    This cohort will receive combination therapy with MEKi.

Study Details

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).

Key Dates

Start date
Feb 7, 2023
Status verified
Apr 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

The number of subjects with no progression. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226
Mandana Kamgar, MD
[email protected]
414-805-4600

Find similar trials in Milwaukee, WI

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Froedtert Hospital and the Medical College of Wisconsin· Milwaukee, WI

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