KX-ORAX-003 A Safety Study of Oraxol in Cancer Patients
Research type
Research Study
Full title
A Safety Study of Oraxol (HM30181 + oral paclitaxel) in Cancer Patients
IRAS ID
243582
Contact name
Louise Rosalyn Carter
Contact email
Sponsor organisation
Athenex, Inc
Eudract number
2017-004578-33
Clinicaltrials.gov Identifier
Universal Trial Number (UTN), U1111-1170-6641
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This research study is being conducted to find out whether Oraxol is safe and well tolerated therapy in patients who have cancer for which paclitaxel would be an appropriate treatment. Oraxol is a combination product of 2 separate drugs; oral paclitaxel and HM30181 tablet, a novel P-glycoprotein (P-gp) inhibitor. Oraxol is intended to allow for oral treatment of cancers that would otherwise be treated with intravenous (IV) paclitaxel.
A new tablet formulation of paclitaxel has also been developed and one of the secondary objectives of the study is to compare the bioavailability of paclitaxel tablets vs the paclitaxel capsule formulation that is currently being utilised in the clinical development of Oraxol. Bioavailability measures the amount of drug that has been absorbed into the blood after a drug dose being administered orally.
The study is looking to enrol approximately 40 patients and will take approximately 15 to 21 months, from the first participant in to last participant out.
During the Treatment Phase, participants will be treated with Oraxol (15mg tablet of HM30181 plus 30mg capsule/tablet formulation of paclitaxel) on 3 consecutive days every week. The study will look at what the body does to the drug by taking and examining blood samples. The newly developed tablet formulation will be used for 1 dosing week (3 consecutive days) in a subgroup of 8 participants (Group B). 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.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0258
Date of REC Opinion
25 Jun 2018
REC opinion
Further Information Favourable Opinion