drugset / Trial / NCT03892018
The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
RandomizedCrossoverOpen-labelTreatment
Summary
This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.
Timeline
- Start
- 2019-08-05
- Primary completion
- 2023-05-12
- Completion
- 2023-05-12
Outcome
Outcome not reported
Stopped (Business): “STUDY HALTED DUE TO FINANCIAL CONTRAINTS”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | HM30181AK-US | Unknown | — | — |
| Comparator | Paclitaxel | Small molecule | — | — |