High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Conditions
Brief summary
Part 1b: • Frequency and severity of TEAEs • Incidence of dose interruptions, dose reductions, and permanent discontinuations of ZN-c3 azenosertib due to related TEAEs, Part 2a: Independent primary endpoints: ORR as defined by RECIST v1.1 and as assessed by the Investigator in subjects with centrally determined cyclin E1-positive status • Frequency and severity of TEAEs, Part 2b: • ORR as defined by RECIST v1.1 and as assessed by ICR in subjects with centrally determined cyclin E1-positive status
Detailed description
Part 1b: • Summarized by cohort and overall: o ORR, DOR, TTR, PFS, and CBR as defined by RECIST v1.1 and as assessed by ICR and the Investigator o OS o CA-125 response by GCIG criteria • Plasma concentrations of azenosertib, Part 2a: • DOR, TTR, PFS, and CBR as defined by RECIST v1.1 and as assessed by the Investigator • OS • CA-125 response by GCIG criteria • ORR and DOR as defined by RECIST v1.1 and as assessed by the Investigator • Systemic plasma concentrations of azenosertib, Part 2b: • Frequency and severity of TEAEs • ORR, DOR, TTR, PFS, and CBR as defined by RECIST v1.1 as assessed by the Investigator • DOR, TTR, PFS, and CBR as defined by RECIST v1.1 as assessed by ICR • OS • CA-125 response by GCIG criteria • ORR and DOR as defined by RECIST v1.1 as assessed by the Investigator
Interventions
DRUGOLANZAPINE
DRUGGRANISETRON
DRUGDEXAMETHASONE
DRUGONDANSETRON
DRUGAPREPITANT
Sponsors
K-Group Beta Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1b: • Frequency and severity of TEAEs • Incidence of dose interruptions, dose reductions, and permanent discontinuations of ZN-c3 azenosertib due to related TEAEs, Part 2a: Independent primary endpoints: ORR as defined by RECIST v1.1 and as assessed by the Investigator in subjects with centrally determined cyclin E1-positive status • Frequency and severity of TEAEs, Part 2b: • ORR as defined by RECIST v1.1 and as assessed by ICR in subjects with centrally determined cyclin E1-positive status | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1b: • Summarized by cohort and overall: o ORR, DOR, TTR, PFS, and CBR as defined by RECIST v1.1 and as assessed by ICR and the Investigator o OS o CA-125 response by GCIG criteria • Plasma concentrations of azenosertib, Part 2a: • DOR, TTR, PFS, and CBR as defined by RECIST v1.1 and as assessed by the Investigator • OS • CA-125 response by GCIG criteria • ORR and DOR as defined by RECIST v1.1 and as assessed by the Investigator • Systemic plasma concentrations of azenosertib, Part 2b: • Frequency and severity of TEAEs • ORR, DOR, TTR, PFS, and CBR as defined by RECIST v1.1 as assessed by the Investigator • DOR, TTR, PFS, and CBR as defined by RECIST v1.1 as assessed by ICR • OS • CA-125 response by GCIG criteria • ORR and DOR as defined by RECIST v1.1 as assessed by the Investigator | — |
Countries
Belgium, France, Italy, Poland, Spain
Outcome results
None listed