1977638
Last Update Posted: 2022-10-18
Recruiting has ended
All Genders accepted | 18 Years + |
51 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Phase 1 Trial of CXD101 in Patients With Advanced Cancer
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.
Eligibility
Relevant conditions:
Advanced Cancer
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
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Contact Information
Overall Contact
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Data sourced from ClinicalTrials.gov