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Active (not recruiting) Phase 3 NCT06608927

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

Phase 3 – large-scale trial before approval
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Sponsor: Arcus Biosciences, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 12
Australia (1)
Chris O'Brien Lifehouse
Camperdown
Belgium (1)
Institut Jules Bordet
Anderlecht
Canada (1)
Ottawa Hospital - General Campus
Ottawa
Czech Republic (1)
Fakultni Nemocnice Brno
Brno
France (1)
Centre Georges François Leclerc
Dijon
Germany (1)
Katholisches Klinikum Bochum - St. Josef-Hospital
Bochum
Italy (1)
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi
Bologna
Japan (1)
National Cancer Center Hospital East
Kashiwa-shi
South Korea (1)
Chonnam National University Hwasun Hospital
Hwasun
Spain (1)
Hospital Clinic de Barcelona
Barcelona
United Kingdom (1)
University Hospitals Birmingham NHS Foundation Trust
Birmingham
United States (1)
Mayo Clinic Arizona - Phoenix Campus
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
13.12.2024
Completion date
30.11.2030
Registry ID
NCT06608927
Source
anzctr
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