drugset / Trial / NCT05084456
Oral Docetaxel in Patients With Normal or Impaired Liver Function
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open label, single centre pharmacological and safety study to define the safety and pharmacokinetics of ModraDoc006/r in a weekly dosing schedule in patients with impaired liver function who might have benefit from a weekly docetaxel regime. The safety of ModraDoc006 in combination with ritonavir for the patients with mild and moderate impaired liver function will be evaluated with a dose escalation design.
Timeline
- Start
- 2017-07
- Primary completion
- 2020-02
- Completion
- 2020-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 10 mg | Oral |
| Subject | Docetaxel | Small molecule | 20 mg | Oral |
| Subject | Docetaxel | Small molecule | 30 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |