drugset / Trial / NCT01298063
Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Up to 38 subjects entered with the aim of entering 8 subjects with mild liver impairment (at highest dose of afatinib), 8 subjects with moderate liver impairment (at either highest dose or two lower doses) and 8 healthy matched controls to each of this two groups.
Timeline
- Start
- 2011-02
- Primary completion
- 2012-01
- Completion
- —
Outcome
Missed primary endpoint
registry analysis (non-inferiority or equivalence test); 50 mg Afatinib Group A vs 50 mg Afatinib Group C; p = 0.1998; Geometric mean ratio 92.64 (90% CI 67.960 to 126.270) NCT01298063 ↗
registry analysis (non-inferiority or equivalence test); 50 mg Afatinib Group A vs 50 mg Afatinib Group C; p = 0.2002; Geometric mean ratio 109.47 (90% CI 82.683 to 144.947) NCT01298063 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afatinib | Small molecule | — | — |