Advanced epithelial ovarian, fallopian tube or peritoneal carcinoma
Conditions
Brief summary
PFS, defined as date of randomization which occurs following surgery to the date of event defined as the first documented progression as per RECIST v1.1 as determined by the investigator or death due to any cause
Detailed description
OS, defined as date of randomization to date of death due to any cause, Incidence of adverse events (AEs) – including AEs, serious AEs (SAEs), deaths, and AEs leading to discontinuation of treatment, frequency/ severity of vital signs measurements, physical examination findings, and changes in clinical laboratory parameters (haematology, biochemistry, urinalysis), Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) and 3 additional questions from the NFOSI-18 in each treatment group.
Interventions
Sponsors
Canariabio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as date of randomization which occurs following surgery to the date of event defined as the first documented progression as per RECIST v1.1 as determined by the investigator or death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, defined as date of randomization to date of death due to any cause, Incidence of adverse events (AEs) – including AEs, serious AEs (SAEs), deaths, and AEs leading to discontinuation of treatment, frequency/ severity of vital signs measurements, physical examination findings, and changes in clinical laboratory parameters (haematology, biochemistry, urinalysis), Change from baseline in the global health status/QOL scale score of the Functional Assessment of Cancer Therapy-Ovary (FACT-O TOI) and 3 additional questions from the NFOSI-18 in each treatment group. | — |
Countries
Belgium, Czechia, Hungary, Italy, Spain
Outcome results
None listed