Safety Study of the Histone Deacetylase Inhibitor, CHR-3996, in Patients With Advanced Solid Tumours
- Registration Number
- NCT00697879
- Lead Sponsor
- Chroma Therapeutics
- Brief Summary
CHR-3996 is one of a new class of anti-cancer agents - histone deacetylase inhibitors (HDACi) - that has exhibited pleiotropic activity both in vitro and in vivo against a range of human cancer cells. Regulation of the acetylation of both histone and non-histone proteins by histone deacetylase enzymes is one of the key mechanisms involved in epigenetic control of gene expression. HDACi have demonstrated activity in both in vitro cytotoxicity, and in vivo tumour xenograft studies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 CHR-3996 Oral, once daily administration of CHR-3996 to determine safety and tolerability
- Primary Outcome Measures
Name Time Method To determine the safety, tolerability, dose-limiting toxicities (DLT), maximum acceptable dose (MAD) and maximum tolerated dose (MTD) of CHR-3996 when administered orally to patients with advanced or treatment refractory solid tumours After 28 days treatment
- Secondary Outcome Measures
Name Time Method To determine pharmacokinetic parameters of CHR-3996 After 1 and 28 days treatment To perform a preliminary assessment of the anti-tumour activity of CHR-3996 During treatment
Trial Locations
- Locations (3)
The Royal Marsden Hospital
🇬🇧Sutton, Surrey, United Kingdom
Erasmus MC University Medical Center - Location Centrum
🇳🇱Rotterdam, Netherlands
Erasmus University Medical Center - Location Daniel den Hoed
🇳🇱Rotterdam, Netherlands