Solid tumor
Conditions
Brief summary
Occurrence of DLTs, Incidence of TEAEs, assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples, Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs
Detailed description
Concentration of INCB099280 in plasma, Objective response, defined as having a best overall response of CR or PR by investigator assessment per RECIST v1.1., Disease control, defined as having a best overall response of CR or PR, or SD of ≥ 15 weeks after initiation of study treatment, by investigator assessment per RECIST v1.1., DOR, defined as the time from the earliest date of CR or PR until the earliest date of disease progression (by investigator assessment per RECIST v1.1) or death due to any cause if occurring sooner than progression.
Interventions
DRUGINCB099280
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
Sponsors
Incyte Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of DLTs, Incidence of TEAEs, assessed by physical examinations, changes in vital signs and ECGs, and analysis of clinical laboratory samples, Incidence of TEAEs leading to dose interruption, dose reduction, or discontinuation of either of the study drugs | — |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of INCB099280 in plasma, Objective response, defined as having a best overall response of CR or PR by investigator assessment per RECIST v1.1., Disease control, defined as having a best overall response of CR or PR, or SD of ≥ 15 weeks after initiation of study treatment, by investigator assessment per RECIST v1.1., DOR, defined as the time from the earliest date of CR or PR until the earliest date of disease progression (by investigator assessment per RECIST v1.1) or death due to any cause if occurring sooner than progression. | — |
Countries
Norway, Slovakia, Sweden
Outcome results
None listed