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Активно (без набиране) Фаза 3 NCT06608927

Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Фаза 3 – широко изпитване преди одобрение
Заболявания: Metastatic Pancreatic Ductal Adenocarcinoma

Спонсор: Arcus Biosciences, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to compare overall survival of quemliclustat, nab-paclitaxel and gemcitabine versus placebo, nab-paclitaxel and gemcitabine in all randomized patients.
Кой може да участва
Inclusion Criteria: * Have histologically or cytologically confirmed PDAC that is metastatic. * Have not been previously treated for PDAC in the metastatic setting. 1. Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization. 2. Prior palliative radiotherapy is allowed if completed at least 2 weeks prior to randomization and AEs have resolved to Grade 1 or less before randomization. 3. Prior and/or placement of a biliary stent/tube is permitted if any treatment-related AEs have improved to Grade ≤ 1 and the patient is not exhibiting any signs/symptoms of biliary obstruction. * Eastern Cooperative Oncology Group PS of 0 to 1. * At least 1 target lesion measurable by computed tomography (CT)/magnetic resonance imaging (MRI) per RECIST v1.1. not within a field of prior radiation therapy. Exclusion Criteria: * Previously treated for locally advanced, unresectable PDAC. * History of brain metastases or leptomeningeal metastases. * Prior treatment with a CD73 antagonist or inhibitor. * Underlying medical conditions that, in the investigator or sponsor's opinion, will make the administration of study-specified therapy hazardous NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Места на провеждане 12
Австралия (1)
Chris O'Brien Lifehouse
Camperdown
Белгия (1)
Institut Jules Bordet
Anderlecht
Канада (1)
Ottawa Hospital - General Campus
Ottawa
Чехия (1)
Fakultni Nemocnice Brno
Brno
Франция (1)
Centre Georges François Leclerc
Dijon
Германия (1)
Katholisches Klinikum Bochum - St. Josef-Hospital
Bochum
Италия (1)
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna
Япония (1)
National Cancer Center Hospital East
Kashiwa-shi
Южна Корея (1)
Chonnam National University Hwasun Hospital
Hwasun
Испания (1)
Hospital Clinic de Barcelona
Barcelona
Великобритания (1)
University Hospitals Birmingham NHS Foundation Trust
Birmingham
САЩ (1)
Mayo Clinic Arizona - Phoenix Campus
Phoenix , Arizona
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
13.12.2024
Крайна дата
30.11.2030
Регистрационен номер
NCT06608927
Източник
anzctr
Запитване за медицински туризъм

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