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

Mandana Kamgar, MD80 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

combination therapy with no MEKiOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Secondary Outcomes

The number of subjects who have a complete response.

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

Time frame: 2 years

The number of subjects who have a partial response.

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

Time frame: 2 years

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.

Time frame: 2 years

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.

Time frame: 2 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts