The purpose of this study is to determine the highest dose of CXD101 (a novel histone deacetylase inhibitor) that can be safely administered to patients with advanced tumours. The study will also investigate the use of HR23B expression in tumour as a biomarker of response to treatment with CXD101. Patients with solid tumours, lymphoma and myeloma can be considered for this study.
Patients will be treated with CXD101 administered orally starting at 1mg twice a day (ie: 2mg/day). Dose escalation will proceed according to a standard 3+3 phase 1 scheme. Adverse experiences will be evaluated according to the NCI Common Terminology Criteria for Adverse Events, version 4.0. Dose escalation will continue until dose limiting toxicity is encountered in \>1/3rd of patients at any dose level. The dose level below this will be determined to be the maximum tolerated dose. Patients will be treated, at the discretion of the Principal Investigator, until disease progression, unacceptable toxicity or the withdrawal of consent. At the maximum tolerated dose a further 20 patients, defined by tumour HR23B expression will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Capsules, administered orally
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, United Kingdom
To determine the maximum tolerated dose of CXD101 administered twice daily for 5 consecutive days every 21 days
Time frame: 18 months
To determine the pharmacokinetic (PK) profile of CXD101 following single and multiple dosing
Time frame: 18 months
To enable a preliminary assessment of the anti-tumour activity of CXD101
Time frame: 24 months
To evaluate the tissue expression of the biomarker HR23B
Time frame: 24 months
To assess the pharmacodynamic effect of CXD101
Time frame: 24 months
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