Trials / Terminated
TerminatedNCT03892018
The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Athenex, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oraxol | Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets. |
Timeline
- Start date
- 2019-08-05
- Primary completion
- 2023-05-12
- Completion
- 2023-05-12
- First posted
- 2019-03-27
- Last updated
- 2023-05-22
Locations
3 sites across 1 country: United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03892018. Inclusion in this directory is not an endorsement.