Pancreatic (PAAD)
Conditions
Brief summary
Objective response rate at Week 16 (ORR-16W) according to RECIST V1.1
Detailed description
• DCR after 16 weeks of treatment (DRC-16W) according to RECIST V1.1 • Best overall response Rate according to RECIST V1.1 • Duration of response (DoR), • Progression Free survival (PFS) • Overall survival (OS), Incidence and severity of AEs (with severity determined according to NCI CTCAE v5.0) including AE related to vital signs and clinical laboratory test results., Changes from baseline in Quality of Life using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire
Interventions
DRUGSaruparib
Sponsors
Centre Leon Berard
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate at Week 16 (ORR-16W) according to RECIST V1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| • DCR after 16 weeks of treatment (DRC-16W) according to RECIST V1.1 • Best overall response Rate according to RECIST V1.1 • Duration of response (DoR), • Progression Free survival (PFS) • Overall survival (OS), Incidence and severity of AEs (with severity determined according to NCI CTCAE v5.0) including AE related to vital signs and clinical laboratory test results., Changes from baseline in Quality of Life using European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire | — |
Countries
France
Outcome results
None listed