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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
610
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Overall Survival (OS)
Time frame: Up to 72 months
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 72 months
Objective response rate (ORR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 72 months
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 72 months
Disease Control Rate (DCR) as determined by the Investigator according to RECIST v1.1
Time frame: Up to 72 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 72 months
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Administered as specified in the treatment arm
Mayo Clinic Arizona - Phoenix Campus
Phoenix, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
University of California San Diego Health
La Jolla, California, 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
Sutter Medical Center
Roseville, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, United States
USOR - Rocky Mountain Cancer Centers - Denver - Midtown
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
...and 115 more locations