Platinum-Resistant Ovarian Cance
Conditions
Brief summary
ZN-c3 with niraparib: • Phase 1: Frequency and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1 (C1)., • Phase 2: – Stage 1 (Futility): Progression-free survival (PFS) at 4 months as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1. – Stage 2 (Promising Clinical Activity): Objective response rate (ORR) as defined by the revised RECIST Guideline version 1.1 and assessed by Independent Central Review (ICR)., ZN-c3 monotherapy: • Frequency and severity of adverse events (AEs), including laboratory abnormalities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. • Incidence of dose interruptions, dose reductions, and permanent treatment discontinuations due to treatment-related AEs • ORR as defined by the revised RECIST Guideline version 1.1 and assessed by ICR.
Detailed description
• Duration of response (DOR) as a key secondary endpoint, Clinical benefit rate (CBR), PFS (median and 4-month rate), as defined by the revised RECIST Guideline version 1.1., ORR based on Investigator assessment using RECIST v 1.1, OS (median at 12 months and overall), Frequency and severity of AEs, including laboratory abnormalities, graded according to the NCI-CTCAE version 5.0., Incidence of dose interruptions, dose reductions, and permanent treatment discontinuations due to treatment-related AEs, Ongoing measurement of subject-reported symptomatic toxicity according to the PRO-CTCAE, and determination of change from Baseline in self-reported quality of life using EQ-5D-5L, Plasma PK parameters of ZN-c3 (and its potential metabolites, as applicable) and niraparib.
Interventions
Sponsors
K-Group Beta Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ZN-c3 with niraparib: • Phase 1: Frequency and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1 (C1)., • Phase 2: – Stage 1 (Futility): Progression-free survival (PFS) at 4 months as defined by the revised Response Evaluation Criteria in Solid Tumors (RECIST) Guideline version 1.1. – Stage 2 (Promising Clinical Activity): Objective response rate (ORR) as defined by the revised RECIST Guideline version 1.1 and assessed by Independent Central Review (ICR)., ZN-c3 monotherapy: • Frequency and severity of adverse events (AEs), including laboratory abnormalities, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. • Incidence of dose interruptions, dose reductions, and permanent treatment discontinuations due to treatment-related AEs • ORR as defined by the revised RECIST Guideline version 1.1 and assessed by ICR. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Duration of response (DOR) as a key secondary endpoint, Clinical benefit rate (CBR), PFS (median and 4-month rate), as defined by the revised RECIST Guideline version 1.1., ORR based on Investigator assessment using RECIST v 1.1, OS (median at 12 months and overall), Frequency and severity of AEs, including laboratory abnormalities, graded according to the NCI-CTCAE version 5.0., Incidence of dose interruptions, dose reductions, and permanent treatment discontinuations due to treatment-related AEs, Ongoing measurement of subject-reported symptomatic toxicity according to the PRO-CTCAE, and determination of change from Baseline in self-reported quality of life using EQ-5D-5L, Plasma PK parameters of ZN-c3 (and its potential metabolites, as applicable) and niraparib. | — |
Countries
France
Outcome results
None listed