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

NCT06608927

Active Not RecruitingPhase 3

Sponsor: Arcus Biosciences, Inc.

Conditions: Metastatic Pancreatic Ductal Adenocarcinoma

Interventions: Quemliclustat, Placebo, Nab-paclitaxel, Gemcitabine

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (111)

Phoenix, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Roseville, California, United States
San Francisco, California, United States
Santa Monica, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Arlington Heights, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Hattiesburg, Mississippi, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
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