Pancreatic Ductal Adenocarcinoma
Conditions
Brief summary
OS, defined as the time from the date of randomization to the date of death due to any cause. PFS by BICR, defined as the time from the date of randomization to the date of the first documented progression as determined by BICR per RECIST v1.1 or death due to any cause. Objective response by BICR, defined as a BOR of CR or PR as determined by BICR per RECIST v1.1.
Detailed description
DOR by BICR, defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death from any cause. Disease control by BICR, defined as having CR, PR, or SD as the best response determined by BICR per RECIST v1.1. PFS by investigator assessment, defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per RECIST v1.1, Objective response by investigator assessment, defined as a BOR of CR or PR as determined by the investigator per RECIST v1.1. • DOR by investigator assessment, defined as the time from the earliest date of documented response until earliest date of disease progression as determined by the investigator per RECIST v1.1 or death from any cause. • Disease control by investigator assessment, defined as having CR, PR, or SD as the best response as determined by the investigator per RECIST v1.1., AEs, assessed by physical examinations, evaluating changes in vital signs and ECGs, and through clinical laboratory blood sample evaluations. • Treatment interruptions, dose reductions, and discontinuation of study treatment due to AEs., HRQoL, assessed by changes from baseline in EORTC QLQ-C30, QLQ-PAN26, and EQ-5D-5L questionnaire scores., Plasma concentration of INCB161734., Blood and/or tumor analytes (which may include genomic analysis of cfDNA and proteomic measurement of markers in blood and genomic, transcriptomic, metabolomic, and/or proteomic markers in tumor tissue) that may correlate with clinical response or resistance to INCB161734 in combination with chemotherapy, Resource utilization associated with unplanned medical encounters.
Interventions
DRUGIRINOTECAN
DRUGA placebo matching incb161734
DRUGINCB161734
DRUGOXALIPLATIN
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGGEMCITABINE
DRUGFLUOROURACIL
DRUGCALCIUM FOLINATE HYDRATE
Sponsors
Incyte Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS, defined as the time from the date of randomization to the date of death due to any cause. PFS by BICR, defined as the time from the date of randomization to the date of the first documented progression as determined by BICR per RECIST v1.1 or death due to any cause. Objective response by BICR, defined as a BOR of CR or PR as determined by BICR per RECIST v1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR by BICR, defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death from any cause. Disease control by BICR, defined as having CR, PR, or SD as the best response determined by BICR per RECIST v1.1. PFS by investigator assessment, defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per RECIST v1.1, Objective response by investigator assessment, defined as a BOR of CR or PR as determined by the investigator per RECIST v1.1. • DOR by investigator assessment, defined as the time from the earliest date of documented response until earliest date of disease progression as determined by the investigator per RECIST v1.1 or death from any cause. • Disease control by investigator assessment, defined as having CR, PR, or SD as the best response as determined by the investigator per RECIST v1.1., AEs, assessed by | — |
Outcome results
None listed