The main purpose of this study is to evaluate the safety and efficacy of the study drug known as galunisertib administered in combination with the anti-programmed cell death-ligand 1 (PD-L1) antibody durvalumab in participants with refractory metastatic pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Administered orally
Administered IV
Honor Health Research Institute
Scottsdale, Arizona, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, United States
Number of Participants with Galunisertib in Combination with Durvalumab Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (28 Days)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Galunisertib
Time frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles)
PK: Area Under the Curve (AUC) at Steady State of Galunisertib
Time frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles)
PK: Minimum Concentration (Cmin) of Durvalumab
Time frame: Predose Day 1 Cycle 1 through Predose Day 1 Cycle 7 (28 Day Cycles)
Number of Participants with Anti-Durvalumab Antibodies
Time frame: Predose Day 1 Cycle 2 through Predose Day 1 Cycle 4 (28 Day Cycles)
Progression-free Survival (PFS)
Time frame: Baseline to Objective Progressive Disease or Death (Estimated up to 18 Months)
Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
Time frame: Baseline to Objective Progressive Disease (Estimated up to 18 Months)
Duration of Response (DoR)
Time frame: Date of CR or PR to Date of Objective Progressive Disease or Death Due to Any Cause (Estimated up to 18 Months)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and Stable Disease (SD)
Time frame: Baseline to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Estimated up to 18 Months)
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Tennessee Oncology PLLC
Nashville, Tennessee, United States
Gustave Roussy
Villejuif, France
Ospedale Policlinico Giambattista Rossi, Borgo Roma
Verona, Italy
Samsung Medical Center
Seoul, Korea, South Korea
Seoul National University Hospital
Seoul, South Korea
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
...and 1 more locations
Time to Response
Time frame: Baseline to Date of CR or PR (Estimated up to 4 Months)
Overall Survival (OS)
Time frame: Baseline to Date of Death from Any Cause (Estimated up to 30 Months)