Advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and are not candidates for curative surgery or radiation., Advanced or unresectable hepatocellular carcinoma in adults who have received no prior systemic therapy., differentiated (papillary/follicular/Hurthle cell) thyroid carcinoma, locally advanced or metastatic, Progressive, refractory to radioactive iodine in adults.
Conditions
Brief summary
The following pharmacokinetic parameters will be estimated: maximum observed plasma concentration (Cmax); time of occurrence of Cmax (tmax); area under the plasma concentration versus time curve (AUC) from pre-dose (time zero) to 72 hours (AUC0-72); apparent terminal elimination rate constant (λz); and apparent terminal elimination half-life (t1/2).
Detailed description
Safety will be evaluated through the assessment of adverse events (AEs), ECG, vital signs and clinical laboratory tests.
Interventions
DRUGLenvatinib
Sponsors
Bluepharma Industria Farmaceutica S.A.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following pharmacokinetic parameters will be estimated: maximum observed plasma concentration (Cmax); time of occurrence of Cmax (tmax); area under the plasma concentration versus time curve (AUC) from pre-dose (time zero) to 72 hours (AUC0-72); apparent terminal elimination rate constant (λz); and apparent terminal elimination half-life (t1/2). | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be evaluated through the assessment of adverse events (AEs), ECG, vital signs and clinical laboratory tests. | — |
Countries
Portugal
Outcome results
None listed