KX-ORADOX-003: Oradoxel Monotherapy in Advanced Solid Malignancies
Research type
Research Study
Full title
A Dose Regimen-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of Oradoxel Monotherapy in Subjects with Advanced Malignancies, delivered in a Modular Format.
IRAS ID
295209
Contact name
Marc Tjwa
Contact email
Sponsor organisation
Athenex, Inc
Eudract number
2020-005788-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1173-5590, Universal Trial Number (UTN)
Duration of Study in the UK
1 years, 10 months, 29 days
Research summary
This research is being conducted to determine the activity, safety, and tolerability of Oradoxel in various advanced cancers with the main aim being to find the safest, effective dose of Oradoxel at different dosing frequencies.
Oradoxel is a combination of 2 different drugs; an oral formulation of an intravenous chemotherapy called docetaxel and HM30181AK-US, a drug which helps the body to absorb docetaxel in the gut. The development of oral chemotherapy treatments could provide patients with a more convenient way for them to be treated for their cancer.
The study consists of two separate modules. Module 1 will enrol a maximum of 40 participants with advanced-solid tumours. Module 2 will enrol approximately 72 participants with advanced prostate cancer.
Study participants will complete a screening period to determine whether they are eligible to take part before undergoing weekly, fortnightly or 3 weekly treatment cycles with 1, 2 or 3 days of dosing in each cycle. The dosing schedule will be assigned based on when participants enter the study.
All participants will attend the clinic for visits on Days 1-5 in Cycle 1 and on up to 6 further occasions in the first 3-4 weeks. Thereafter, participants will have a weekly clinic visit and telephone calls until they or their doctor feel that treatment should be stopped, following which they will have one final ‘follow up’ visit.
Clinic assessments include CT/MRI and bone scans every 12 weeks and blood cancer marker tests at screening and then every 6 (Module 2) or 12 weeks (Module 1) thereafter as applicable; 6 weekly ECGs; up to 20 PK blood samples within 8 days of first dosing; regular vital signs, weight and physical exam assessments; routine safety blood and urine samples and an assessment of how cancer affects the participants daily living abilities.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0509
Date of REC Opinion
29 Jul 2021
REC opinion
Favourable Opinion