This is a Phase 1/2 trial to evaluate the safety, tolerability, and efficacy of FG-3019 administered with gemcitabine and nab-paclitaxel in the treatment of locally advanced, unresectable pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
FG-3019 will be administered per dose and schedule specified in the arm group description.
Gemcitabine will be administered per dose and schedule specified in the arm group description.
Nab-paclitaxel will be administered per dose and schedule specified in the arm group description.
HonorHealth Research Institute
Scottsdale, Arizona, United States
University of California, Los Angeles
Los Angeles, California, United States
Georgetown University - Medstar Health Research Institute
Washington D.C., District of Columbia, United States
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A TEAE was defined as a new or worsening AE that occurred in the window of first infusion of any study drug (Day 1) and within 28 days of the last infusion of study drug or the day before surgery, whichever occurred first. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
Time frame: From first infusion of any study drug (Day 1) up to 28 days after last infusion of study drug or the day before surgery (up to Day 196)
Number of Participants Who Had Surgical Complications Post-Resection
Number of participants who had surgical complications (for example; surgical site infection, intra-abdominal abscess, or perioperative leak during surgery) has been reported
Time frame: 30 days following discharge after surgery (up to Day 198)
Number of Participants Who Became Eligible for Surgery
Time frame: After completion of 24 weeks of treatment with study drug
Number of Participants in Whom R0 Resection Was Achieved
R0 resection was determined by pathological examination of the surgical specimen after resection.
Time frame: After completion of 24 weeks of treatment with study drug
Number of Participants in Whom R0 or R1 Resection Was Achieved
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic Florida
Jacksonville, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Virginia Mason Medical Center - Benaroya Research Institute
Seattle, Washington, United States
R0 or R1 resection was determined by pathological examination of the surgical specimen after resection.
Time frame: After completion of 24 weeks of treatment with study drug
Number of Participants With Complete Response (CR) or Partial Response (PR) Per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduced in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time frame: From randomization up to Week 52
Median Overall Survival
Overall survival was defined as the time from randomization until death from any cause.
Time frame: From randomization until death from any cause, assessed up to 4 years
Median Progression-Free Survival
Progression-free survival was defined as the time from randomization until objective tumor progression or death. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Time frame: From randomization until objective tumor progression or death, assessed up to 4 years