Locally Advanced or Metastatic Cholangiocarcinoma
Conditions
Brief summary
AEs, serious AEs (SAEs), AEs of special interest (AESIs), AEs leading to discontinuation or death, safety laboratory parameters, 12-lead ECG, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Detailed description
• Response to treatment based on tumor assessments by the investigator according to local clinical practice o Progression-free survival (PFS) o Overall survival (OS) o Duration of response (DOR) o Time to response (TTR), • HRQOL as assessed by the validated European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21), • Health economic outcomes as assessed by the 5 level EuroQol 5-dimensional questionnaire (EQ-5D-5L), • Proportion of days at home or hospital, • Concomitant medications
Interventions
DRUGIVOSIDENIB
Sponsors
Servier Affaires Medicales
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs, serious AEs (SAEs), AEs of special interest (AESIs), AEs leading to discontinuation or death, safety laboratory parameters, 12-lead ECG, vital signs, Eastern Cooperative Oncology Group (ECOG) performance status (PS) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Response to treatment based on tumor assessments by the investigator according to local clinical practice o Progression-free survival (PFS) o Overall survival (OS) o Duration of response (DOR) o Time to response (TTR), • HRQOL as assessed by the validated European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cholangiocarcinoma and Gallbladder Cancer Module (QLQ-BIL21), • Health economic outcomes as assessed by the 5 level EuroQol 5-dimensional questionnaire (EQ-5D-5L), • Proportion of days at home or hospital, • Concomitant medications | — |
Countries
Austria, Germany, Netherlands, Sweden
Outcome results
None listed