MUK three
Research type
Research Study
Full title
A phase 1/2a, dose escalation study of CHR-3996 in combination with tosedostat in subjects with relapsed, refractory multiple myeloma
IRAS ID
75733
Contact name
Rakesh Popat
Contact email
Sponsor organisation
University of Leeds
Eudract number
2011-001914-33
ISRCTN Number
ISRCTN24989786
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Multiple myeloma is a malignant disorder of bone marrow plasma cells. It affects over 3500 new individuals each year in the UK and is presently incurable. High dose chemotherapy is associated with a median survival of 4.5 years but all patients eventually relapse. Despite the introduction of a number of novel treatments, including thalidomide, lenalidomide and bortezomib, all patients become resistant to these and new therapies are required.
Inhibition of HDAC enzymes has emerged as a strategy to reverse aberrant epigenetic changes associated with cancer. Although in vitro and in vivo data suggest HDAC inhibitors such as CH-3996 have an anti-myeloma effect, it seems unlikely that this class of drugs will be used in the clinic as monotherapy. However there is strong preclinical rationale supporting the combination of a HDAC inhibitor and an aminopeptidase inhibitor, such as tosedostat in myeloma.
Phase I studies demonstrate that both CHR-3996 and tosedostat are safe and tolerable when dosed as monotherapy. The purpose of this study is therefore to determine the safety and preliminary activity of CHR-3996 administered in combination with tosedostat in subjects with relapsed, refractory multiple myeloma.REC name
London - Chelsea Research Ethics Committee
REC reference
11/LO/1362
Date of REC Opinion
20 Oct 2011
REC opinion
Further Information Favourable Opinion