Идёт набор NCT05630989

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

— Наблюдательное Pancreatic Ductal Adenocarcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: combination therapy with no MEKi, combination therapy with MEKi-HCQ, combination therapy with MEKi-EGFRi, combination therapy with MEKi..
Кому может быть актуально: Состояния в реестре: Pancreatic Ductal Adenocarcinoma. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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).

Подробное описание

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.

Вмешательства

Другое combination therapy with no MEKi
This cohort will receive combination therapy with no MEKi.
Препарат combination therapy with MEKi-HCQ
This cohort will receive combination therapy with MEKi-HCQ.
Препарат combination therapy with MEKi-EGFRi
This cohort will receive combination therapy with MEKi-EGFRi.
Препарат combination therapy with MEKi.
This cohort will receive combination therapy with MEKi.

Первичные конечные точки

The number of subjects with no progression. [Срок оценки: 6 months]

Вторичные конечные точки (4)

The number of subjects who have a complete response. [Срок оценки: 2 years]
The number of subjects who have a partial response. [Срок оценки: 2 years]
The number of grade 3 adverse events at least possibly related to a drug. [Срок оценки: 2 years]
The number of grade 4 adverse events at least possibly related to a drug. [Срок оценки: 2 years]

Критерии участия

Критерии включения

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.