A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients
Status:
Completed
Trial end date:
2021-06-15
Target enrollment:
Participant gender:
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).