Endometrial Cancer
Conditions
Brief summary
PFS (per RECIST 1.1 as assessed by investigator) is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression).
Detailed description
PFS2: Second progression-free survival is defined as the time from randomisation to the earliest of progression event subsequent to first subsequent therapy (assessed by the investigator per local standard clinical practice and may involve any of the following: objective radiological imaging, symptomatic progression), or death due to any cause., OS: Overall survival is defined as the time from the date of randomisation until death due to any cause., ORR: Objective response rate is the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR), as determined by the investigator at local site., DoR: Duration of response is time from the date of first documented response (subsequently confirmed) until date of documented progression or death in the absence of disease progression, as determined by the investigator at local site., TFST: Time to first subsequent therapy or death is time from randomisation to the earlier of start date of the first subsequent anticancer therapy after discontinuation of randomised treatment or death due to any cause., TSST: Time to second subsequent therapy or death is time from randomisation to the earlier of start date of the second subsequent anticancer therapy after discontinuation of first subsequent treatment or death due to any cause., TDT: Time to study treatment discontinuation or death is time from randomisation to the earlier of the date of study treatment discontinuation or death., Serum concentrations of durvalumab, Anti-drug antibodies (ADA) to durvalumab, Safety and tolerability will be evaluated in terms of AEs/serious AEs (SAEs), physical examination, vital signs including blood pressure, pulse, clinical laboratory including clinical chemistry/haematology parameters, and ECG
Interventions
DRUGMyfenax 250 mg hard capsules
DRUGLynparza 100 mg film-coated tablets
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGImfinzi 50 mg/ml
DRUGLynparza 100 mg
DRUGLynparza 150 mg
DRUGLynparza 150 mg film-coated tablets
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS (per RECIST 1.1 as assessed by investigator) is defined as the time from randomisation until the date of objective disease progression or death (by any cause in the absence of progression). | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS2: Second progression-free survival is defined as the time from randomisation to the earliest of progression event subsequent to first subsequent therapy (assessed by the investigator per local standard clinical practice and may involve any of the following: objective radiological imaging, symptomatic progression), or death due to any cause., OS: Overall survival is defined as the time from the date of randomisation until death due to any cause., ORR: Objective response rate is the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR), as determined by the investigator at local site., DoR: Duration of response is time from the date of first documented response (subsequently confirmed) until date of documented progression or death in the absence of disease progression, as determined by the investigator at local site., TFST: Time to first subsequent therapy or death is time from randomisation to the earlier of sta | — |
Countries
Belgium, Estonia, Germany, Greece, Hungary, Lithuania, Poland, Spain
Outcome results
None listed