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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630989
• Other study ID #: PRO00045718
• Status: Recruiting
• Start date: February 7, 2023
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Medical College of Wisconsin
• Contact: Mandana Kamgar, MD, MPH
• Phone: 414-805-4600
• Email: mkamgar[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma

Intervention

Other:
• combination therapy with no MEKi
This cohort will receive combination therapy with no MEKi.

Drug:
• combination therapy with MEKi-HCQ
This cohort will receive combination therapy with MEKi-HCQ.
• combination therapy with MEKi-EGFRi
This cohort will receive combination therapy with MEKi-EGFRi.
• combination therapy with MEKi.
This cohort will receive combination therapy with MEKi.

Locations

Country	Name	City	State
United States	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Mandana Kamgar, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number of subjects who have a complete response.	A complete response will be determined using RECIST v1.1.	2 years
Secondary	The number of subjects who have a partial response.	A partial response will be determined using RECIST v1.1.	2 years
Secondary	The number of grade 3 adverse events at least possibly related to a drug.	Adverse events and serious adverse events will be classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.	2 years
Secondary	The number of grade 4 adverse events at least possibly related to a drug.	Adverse events and serious adverse events will be classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.	2 years