Metastatic pancreatic ductal adenocarcinoma (mPDAC)
Conditions
Brief summary
Progression Free Survival (PFS) between two arms PFS is defined as the time from randomization to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first. PFS will be censored at the time of the last available tumor assessment documenting absence of progressive disease for patients alive at the time of analysis.
Detailed description
To compare the two arms in terms of: • Objective Tumor Response Rate (ORR) • Disease Control Rate (DCR) • Duration of Objective response (DOR) • CA19.9 level reduction • Overall survival (OS) • Overall toxicity rate • Quality of life (QoL), To evaluate mechanistically–based pharmacokinetic and pharmacodynamic biomarkers on blood samples., To explore prognostic factors and predictive biomarkers for response and toxicity on blood samples as well as primary tumors and resected metastases when available
Interventions
DRUGAbraxane 5 mg/ml powder for dispersion for infusion.
DRUGCISPLATIN
DRUGVALPROIC ACID
DRUGSIMVASTATIN
DRUGCAPECITABINE
DRUGGEMCITABINE
Sponsors
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) between two arms PFS is defined as the time from randomization to the first documentation of objective disease progression by RECIST 1.1 criteria, or death due to any cause, whichever occurs first. PFS will be censored at the time of the last available tumor assessment documenting absence of progressive disease for patients alive at the time of analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the two arms in terms of: • Objective Tumor Response Rate (ORR) • Disease Control Rate (DCR) • Duration of Objective response (DOR) • CA19.9 level reduction • Overall survival (OS) • Overall toxicity rate • Quality of life (QoL), To evaluate mechanistically–based pharmacokinetic and pharmacodynamic biomarkers on blood samples., To explore prognostic factors and predictive biomarkers for response and toxicity on blood samples as well as primary tumors and resected metastases when available | — |
Countries
Italy, Spain
Outcome results
None listed