Metastatic Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
Quemliclustat, CD73 Inhibitor, Metastatic Pancreatic Ductal Adenocarcinoma, Treatment naive, Pancreatic cancer, PRISM-1
Brief summary
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.
Interventions
DRUGQuemliclustat
Administered as specified in the treatment arm
DRUGPlacebo
Administered as specified in the treatment arm
DRUGNab-paclitaxel
Administered as specified in the treatment arm
DRUGGemcitabine
Administered as specified in the treatment arm
Sponsors
Arcus Biosciences, Inc.
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | Up to 72 months |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1 | Up to 72 months |
| Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1 | Up to 72 months |
| Duration of response (DoR) as determined by the Investigator according to RECIST v1.1 | Up to 72 months |
| Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1 | Up to 72 months |
| The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) | Up to 72 months |
Countries
Australia, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Japan, South Korea, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORMedical Director
Arcus Biosciences
Outcome results
None listed