A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients

NCT04180384 PHASE2 COMPLETED

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).

Details

Lead sponsor	Athenex, Inc.
Phase	PHASE2
Status	COMPLETED
Enrolment	44
Start date	Wed Sep 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Tue Jun 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Solid Tumor

Interventions

• Oraxol

Countries

New Zealand, United Kingdom, Australia, Taiwan