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