Neoplasms
Conditions
Brief summary
Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period, Part 1 - Proportion of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period, Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period, Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period, Part 1 - Percentage of Participants who require dosage interruptions, dose reductions, and drug discontinuations due to adverse reactions during DLT Observation Period, Part 2 - Confirmed Objective Response Rate (ORR)
Detailed description
Part 1 - Area Under Curve (AUC), Time to Maximum Concentration, and half-life of GSK4364973, Part 1 and 2 - Maximum Concentration (Cmax) of GSK4364973, Part 1 and 2 - Plasma Concentration of Niraparib, Part 1 - Number of Participants with TEAEs and SAEs based on Severity beyond DLT Observation Period, Part 1 - Duration of TEAEs and SAEs (Days) beyond DLT Observation Period, Part 2 - Number of Participants with TEAEs and SAEs based on Severity, Part 2 - Duration of Treatment Emergent AEs and SAEs (Days), Part 2 - Progression-free Survival (PFS), Part 2 - Duration of Response (DOR), Part 2 - Minimum Concentration (Cmin) of GSK4364973
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 - Proportion of Participants with Dose Limiting Toxicities (DLTs) during DLT Observation Period, Part 1 - Proportion of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) based on Severity during DLT Observation Period, Part 1 - Duration of Treatment Emergent AEs and SAEs (Days) during DLT Observation Period, Part 1 - Percentage of Participants who receive all Planned Doses during DLT Observation Period, Part 1 - Percentage of Participants who require dosage interruptions, dose reductions, and drug discontinuations due to adverse reactions during DLT Observation Period, Part 2 - Confirmed Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 - Area Under Curve (AUC), Time to Maximum Concentration, and half-life of GSK4364973, Part 1 and 2 - Maximum Concentration (Cmax) of GSK4364973, Part 1 and 2 - Plasma Concentration of Niraparib, Part 1 - Number of Participants with TEAEs and SAEs based on Severity beyond DLT Observation Period, Part 1 - Duration of TEAEs and SAEs (Days) beyond DLT Observation Period, Part 2 - Number of Participants with TEAEs and SAEs based on Severity, Part 2 - Duration of Treatment Emergent AEs and SAEs (Days), Part 2 - Progression-free Survival (PFS), Part 2 - Duration of Response (DOR), Part 2 - Minimum Concentration (Cmin) of GSK4364973 | — |
Countries
Belgium, Czechia, Denmark, Estonia, Greece, Italy, Romania, Spain