Metastatic pancreatic ductal adenocarcinoma
Conditions
Brief summary
Part 1: Incidence of DLTs, Part 2 and Part 3: Objective response rate (ORR).
Detailed description
Best Overall Response (BOR), with response categories CR, PR, SD, and PD, Duration of response (DoR), Duration of SD, Disease control rate, Time to next anti-cancer therapy, Progression-free survival (PFS), Overall survival (OS), Type, frequency and severity of AEs, Detection and characterization of anti-drug antibody (ADA) titers in serum, PK parameters will include Cmax, Tmax, and AUC(0-T). Additional parameters may be calculated depending on data obtained, Part 1: Objective response rate (ORR)
Interventions
DRUGCALCIUM LEVOFOLINATE
DRUGIRINOTECAN
DRUGCALCIUM FOLINATE
DRUGPACLITAXEL
DRUGGEMCITABINE
DRUGSODIUM FOLINATE
DRUGOXALIPLATIN
DRUGFLUOROURACIL
Sponsors
Alligator Bioscience AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Incidence of DLTs, Part 2 and Part 3: Objective response rate (ORR). | — |
Secondary
| Measure | Time frame |
|---|---|
| Best Overall Response (BOR), with response categories CR, PR, SD, and PD, Duration of response (DoR), Duration of SD, Disease control rate, Time to next anti-cancer therapy, Progression-free survival (PFS), Overall survival (OS), Type, frequency and severity of AEs, Detection and characterization of anti-drug antibody (ADA) titers in serum, PK parameters will include Cmax, Tmax, and AUC(0-T). Additional parameters may be calculated depending on data obtained, Part 1: Objective response rate (ORR) | — |
Countries
Belgium, France, Spain
Outcome results
None listed