A pilot study of Oraxol in Subjects with Cutaneous Angiosarcoma
Research type
Research Study
Full title
A PILOT STUDY OF ORAXOL IN SUBJECTS WITH CUTANEOUS ANGIOSARCOMA
IRAS ID
266381
Contact name
ROBIN JONES
Contact email
Sponsor organisation
Athenex, Inc
Eudract number
2019-002085-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
This research is being conducted to determine the activity, safety and tolerability of Oraxol, an oral formulation of paclitaxel, in patients who have cutaneous angiosarcoma.
Oraxol is a combination product of 2 separate drugs; an oral paclitaxel capsule and HM30181AK-US tablet, a novel Glycoprotein (P-gp) inhibitor which helps the body to absorb paclitaxel. Oraxol is intended to allow for oral treatment of cancers that would otherwise be treated with intravenous (IV) paclitaxel. Oraxol could provide patients with cutaneous angiosarcoma with a safe and more convenient way to be treated for their cancer.
This study is looking to enrol approximately 10 subjects in the UK (25 patients globally) and will take approximately 48 months from the first participant in to the last participant out. The study contains 5 periods. Screening, Baseline, Treatment, Treatment Extension and Follow up. Following screening and baseline assessments, all subjects will be given the study drug, Oraxol (15mg tablet of HM30181AK-US plus 205mg/m2 paclitaxel tablets) for 3 consecutive days every week for up to 25 weeks. Subjects who do not have documented disease progression by the end of the Treatment Period will be eligible to receive additional doses of Oraxol in the Treatment Extension Period from week 26 onwards.
They may continue to take the study drug during the Treatment Extension Period until they meet any of the withdrawal criteria. During the Treatment and Treatment Extension Periods, subjects will come to the clinic to have assessments to check the safety, tolerability and activity of the study drug. A Final visit will take place after completion of treatment. After the Final Visit subjects will be contacted by telephone every 3 months for up to 2 years to assess overall survival.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0676
Date of REC Opinion
30 Dec 2019
REC opinion
Further Information Favourable Opinion