A Safety Study of Oraxol (HM30181 + Oral Paclitaxel) in Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: For 1 dosing week (at least 1 week following the paclitaxel capsule PK sampling period, ie, at Week 5 or later), a subgroup of 8 participants (Group B) will receive Oraxol as HM30181 plus a tablet formulation of paclitaxel. For the remainder of the study, Group B participants will receive the current clinical capsule formulation of paclitaxel. This will allow for comparison of the bioavailability of these 2 formulations with minimal impact on safety or activity.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 wh...
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. Once the dose of Oraxol has been confirmed in the KX-ORAX-002 study, then enrollment of patients who have not participated in the KX-ORAX-002 study can be allowed. 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). Participants in Group B (N=8) will receive the same weekly paclitaxel capsule treatment as the remainder of the subjects except for 1 dosing week (at least 1 week following the paclitaxel capsule PK sampling period) during which they will receive paclitaxel tablets and undergo PK assessments.
Tracking Information
- NCT #
- NCT04180384
- Collaborators
- Zenith Technology Corporation Limited
- PharmaEssentia
- Investigators
- Principal Investigator: Jackson Christopher, MD Dunedin Hospital
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