Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
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: Zoldonrasib, Placebo, Oxaliplatin, Leucovorin (Calcium Folinate).
- Кому может быть актуально
- Состояния в реестре: Pancreatic Cancer, Pancreatic Cancer Metastatic, PDAC, PDAC - 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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Официальное название
RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma
Обзор
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.
Подробное описание
This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with Investigator choice of chemotherapy will improve progression-free survival or overall survival compared to placebo in combination with Investigator choice of chemotherapy when given to patients with previously untreated, 1L metastatic KRAS G12D-mutated pancreatic adenocarcinoma. Choice of chemotherapy (mFFX or GnP) will be at the discretion of the Investigator.
Patients will be randomized to one of two arms: zoldonrasib + Investigator choice of chemotherapy (Arm A) or placebo + Investigator choice of chemotherapy (Arm B).
Вмешательства
- Препарат Zoldonrasib
oral tablets - Препарат Placebo
oral tablets - Препарат Oxaliplatin
IV infusion - Препарат Leucovorin (Calcium Folinate)
IV infusion - Препарат 5-Fluorouracil
IV infusion - Препарат Irinotecan
IV infusion - Препарат Gemcitabine (GEM)
IV infusion - Препарат Nab-paclitaxel
IV infusion
Первичные конечные точки
- Progression free survival (PFS) [Срок оценки: Up to approximately 4 years]
- Overall survival (OS) [Срок оценки: Up to approximately 4 years]
Вторичные конечные точки (9)
- PFS per blinded independent central review (BICR) [Срок оценки: Up to approximately 4 years]
- Objective response rate (ORR) [Срок оценки: Up to approximately 4 years]
- Duration of response (DOR) [Срок оценки: Up to approximately 4 years]
- Incidence of adverse events (AEs) [Срок оценки: Up to approximately 4 years]
- Changes in vital signs [Срок оценки: Up to approximately 4 years]
- Changes in clinical laboratory test values [Срок оценки: Up to approximately 4 years]
- Health-related outcome assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) pain scale [Срок оценки: Up to approximately 4 years]
- Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status score [Срок оценки: Up to approximately 4 years]
- Concentration of zoldonrasib in Arm A [Срок оценки: Up to Cycle 5 Day 1 (each cycle is 28 days)]
Критерии участия
Критерии включения
- At least 18 years old and has provided informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically or cytologically confirmed pancreatic adenocarcinoma.
- Diagnosis of metastatic disease ≤ 6 weeks prior to screening.
- Documented KRAS G12D mutation status.
- Measurable disease per RECIST v1.1.
- Adequate organ function (bone marrow, liver, kidney, coagulation).
- Able to take oral medications.
Критерии исключения
- Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.
- Prior systemic RAS-targeted therapy any time prior to randomization.
- Presence of other known driver mutations with approved targeted therapies
- Active or known history of untreated central nervous system metastatic disease.
- Any conditions that may affect the ability to take or absorb study drug.
- Major surgery within 28 days prior to randomization.
- Patient is unable or unwilling to comply with protocol-required study visits or procedures.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 5 центров
- The University of Arizona Cancer Center-North Campus — Tucson
- Moffitt Cancer Center — Tampa
- Piedmont Healthcare — Atlanta
- University of Chicago Medical Center — Chicago
- Johns Hopkins University — Baltimore
Идентификаторы
NCT: NCT07621718 · RMC-9805-305