Cancer
Conditions
Brief summary
Occurrence of dose-limiting toxicities (DLTs) during the DLT observation period and occurrence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), adverse events of special interest (AESIs), serious advers events (SAEs) and adverse events (AEs) leading to treatment discontinuation.
Detailed description
Occurrence of DLTs, TEAEs, TRAEs, AESIs, SAEs, and AEs leading to treatment discontinuation., Measurement of pharmacokinetics parameters: maximum (peak) observed plasma concentration [Cmax] and time of maximum (peak) observed plasma concentration [Tmax]., Measurement of anti-tumour activity parameters: overall response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease (SD).
Interventions
None listed
Sponsors
Domain Therapeutics Australia Pty Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dose-limiting toxicities (DLTs) during the DLT observation period and occurrence of treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), adverse events of special interest (AESIs), serious advers events (SAEs) and adverse events (AEs) leading to treatment discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of DLTs, TEAEs, TRAEs, AESIs, SAEs, and AEs leading to treatment discontinuation., Measurement of pharmacokinetics parameters: maximum (peak) observed plasma concentration [Cmax] and time of maximum (peak) observed plasma concentration [Tmax]., Measurement of anti-tumour activity parameters: overall response rate (ORR), disease control rate (DCR), duration of response (DOR), duration of stable disease (SD). | — |
Countries
France
Outcome results
None listed