drugset / Trial / NCT04180384
A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients
Phase 2
Completed
44 enrolled
Athenex, Inc.
PharmaEssentia · collabZenith Technology Corporation Limited · collab
Non-randomizedFactorialOpen-labelTreatment
Summary
Oraxol is a combination of an oral tablet, HM30181 methanesulfonate, and capsules that contain paclitaxel. HM30181 is a drug that helps the body absorb paclitaxel, a drug used to treat cancer. Initially this study is intended as an extension study of KX-ORAX-002 pharmacokinetic study for patients who wish to continue Oraxol treatment and who are eligible to participate. The purpose of this study is to check the safety and tolerability of Oraxol when it is administered on a weekly basis and to confirm the sustained oral bioavailability of paclitaxel following multiple dosing; also compare the relative bioavailability of paclitaxel tablets vs paclitaxel capsules (Group B only).
Timeline
- Start
- 2015-09-23
- Primary completion
- 2021-06-15
- Completion
- 2021-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 30 mg | Oral |
| Background | HM30181AK | Unknown | 15 mg | Oral |