recurrent or persistent uterine serous carcinoma
Conditions
Brief summary
Part 1b: • Frequency and severity of TEAEs, including laboratory abnormalities, graded according to the NCI-CTCAE v5.0 • Incidence of dose interruptions, dose reductions, and permanent discontinuations of ZN-c3 due to ZN-c3–related TEAEs, Part 2: • ORR as defined by the revised RECIST v1.1 as assessed by ICR
Detailed description
Part 1b •ORR, DOR, PFS, CBR, and TTR as defined by the revised RECIST v1.1. •OS •Plasma PK concentrations of ZN-c3, Part 2 •DOR as defined by RECIST v1.1. and assessed by ICR •PFS, CBR, and TTR as defined by RECIST v1.1. and assessed by ICR •ORR, PFS, CBR, and TTR as defined by RECIST v1.1. and assessed by the Investigator •OS •Frequency and severity of TEAEs •Association of key biomarkers with clinical outcome of ZN-c3 activity •Plasma PK concentrations of ZN-c3
Interventions
Sponsors
K-Group Beta Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Part 1b •ORR, DOR, PFS, CBR, and TTR as defined by the revised RECIST v1.1. •OS •Plasma PK concentrations of ZN-c3, Part 2 •DOR as defined by RECIST v1.1. and assessed by ICR •PFS, CBR, and TTR as defined by RECIST v1.1. and assessed by ICR •ORR, PFS, CBR, and TTR as defined by RECIST v1.1. and assessed by the Investigator •OS •Frequency and severity of TEAEs •Association of key biomarkers with clinical outcome of ZN-c3 activity •Plasma PK concentrations of ZN-c3 | — |
Primary
| Measure | Time frame |
|---|---|
| Part 1b: • Frequency and severity of TEAEs, including laboratory abnormalities, graded according to the NCI-CTCAE v5.0 • Incidence of dose interruptions, dose reductions, and permanent discontinuations of ZN-c3 due to ZN-c3–related TEAEs, Part 2: • ORR as defined by the revised RECIST v1.1 as assessed by ICR | — |
Countries
France, Italy, Spain
Outcome results
None listed