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., Progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hurthle cell) thyroid carcinoma, refractory to radioactive iodine in adults., Advanced or unresectable hepatocellular carcinoma in adults who have received no prior systemic therapy.
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