Phase I Trial of CXD101 in Patients with Advanced Cancer
Research type
Research Study
Full title
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CXD101 Given Orally (twice daily dosing for 5 consecutive days in a 21-day period) in Patients with Advanced Malignancies Expressing the Biomarker HR23B
IRAS ID
27138
Contact name
Graham Collins
Contact email
Sponsor organisation
Oxford University Hospitals NHS Foundation Trust
Eudract number
2009-021743-42
Duration of Study in the UK
2 years, months, days
Research summary
The study is the first in which CXD101 is being given to patients. The aim of the trial is to define a safe dose of CXD101 for future study. Patients will be treated with CXD101 given orally starting at 2mg/day. Subsequent patients will receive a higher dose according to the side effects experienced by those already treated. At the maximum tolerated dose a further 20 patients, defined by tumour HR23B expression or melanin production, will be given CXD101 to gain a better understanding of its effects on patients and their cancer.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
09/H0606/102
Date of REC Opinion
30 Nov 2009
REC opinion
Further Information Favourable Opinion