Study of Quemliclustat and Chemotherapy Versus Placebo and Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
- Conditions
- Metastatic Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT06608927
- Lead Sponsor
- Arcus Biosciences, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 610
-
Have histologically or cytologically confirmed PDAC that is metastatic.
-
Have not been previously treated for PDAC in the metastatic setting.
- Prior neoadjuvant and/or adjuvant therapy for PDAC is permitted if completed at least 12 months before randomization.
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B (Comparator Arm) Nab-paclitaxel Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm B (Comparator Arm) Gemcitabine Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm A (Experimental Arm) Quemliclustat Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm A (Experimental Arm) Nab-paclitaxel Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm A (Experimental Arm) Gemcitabine Quemliclustat, nab-paclitaxel and gemcitabine will be administered by IV infusion Arm B (Comparator Arm) Placebo Placebo, nab-paclitaxel and gemcitabine will be administered by IV infusion
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 72 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (83)
Gustave Roussy
🇫🇷Villejuif, France
Krankenhaus Nordwest
🇩🇪Frankfurt am Main, Germany
Ospedale di Cremona
🇮🇹Cremona, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Ospedale Guglielmo da Saliceto
🇮🇹Piacenza, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Azienda Ospedaliero Universitaria Delle Marche
🇮🇹Torrette, Italy
Sunnybrook Health Sciences Centre - Bayview Campus
🇨🇦Toronto, Canada
Hôpital Huriez
🇫🇷Lille Cedex, France
Centre Léon Bérard
🇫🇷Lyon, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, France
Katholisches Marienkrankenhaus
🇩🇪Hamburg, Germany
SLK-Kliniken Heilbronn - Klinikum am Gesundbrunnen
🇩🇪Heilbronn, Germany
Fondazione IRCCS - Istituto Nazionale dei Tumori
🇮🇹Milano, Italy
IRCCS Istituto Nazionale Tumori Regina Elena
🇮🇹Roma, Italy
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
USOR - Rocky Mountain Cancer Centers - Denver - Midtown
🇺🇸Denver, Colorado, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Cancer Center of Kansas - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
New York University Medical Oncology Associates
🇺🇸New York, New York, United States
Mount Sinai Medical Center Comprehensive Cancer Center
🇺🇸New York, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Chris O'Brien Lifehouse
🇦🇺Camperdown, Australia
Monash Health
🇦🇺Clayton, Australia
Institut Jules Bordet
🇧🇪Anderlecht, Belgium
Ottawa Hospital - General Campus
🇨🇦Ottawa, Canada
Centre Georges François Leclerc
🇫🇷Dijon cedex, France
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Mayo Clinic Arizona - Phoenix Campus
🇺🇸Phoenix, Arizona, United States
Cancer & Blood Specialty Clinic - Los Alamitos
🇺🇸Los Alamitos, California, United States
Keck Medicine of USC - Keck Hospital of USC
🇺🇸Los Angeles, California, United States
UCLA Health - Santa Monica Cancer Care
🇺🇸Santa Monica, California, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hull University Teaching Hospitals NHS Trust
🇬🇧Cottingham, United Kingdom
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Miami Cancer Institute
🇺🇸Miami, Florida, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Mary Bird Perkins Cancer Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
🇺🇸Chicago, Illinois, United States
Cancer & Hematology Centers of Western Michigan - Lemmen-Holton Cancer Pavilion
🇺🇸Grand Rapids, Michigan, United States
HealthPartners Cancer Research Center - Cancer Center at Regions Hospital
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
MediSync Clinical Research - Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Clinical Research Alliance
🇺🇸New Hyde Park, New York, United States
Columbia University Irving Medical Center - Herbert Irving Pavilion
🇺🇸New York, New York, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Summit Cancer Centers - Spokane Valley
🇺🇸Spokane, Washington, United States
University of Wisconsin - Madison
🇺🇸Madison, Wisconsin, United States
Oncology West - Murdoch
🇦🇺Murdoch, Australia
Wollongong Hospital
🇦🇺Wollongong, Australia
Universitätsklinikum Sankt Pölten
🇦🇹Sankt Pölten, Austria
Krankenhaus Der Barmherzigen Brüder Wien
🇦🇹Wien, Austria
Imeldaziekenhuis
🇧🇪Bonheiden, Belgium
Clínica Universidad de Navarra - Madrid
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Japan
National Cancer Center Hospital
🇯🇵Tokyo, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
Yamaguchi University Hospital
🇯🇵Ube, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-Shi, Japan
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Cha Bundang Medical Center
🇰🇷Seongnam, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Universitari Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Clinica Universidad de Navarra - Pamplona
🇪🇸Pamplona, Spain
Sarah Cannon Research Institute London
🇬🇧London, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Oxford, United Kingdom