Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Chroma Therapeutics |
---|---|
Information provided by: | Chroma Therapeutics |
ClinicalTrials.gov Identifier: | NCT00697879 |
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
Condition | Intervention | Phase |
---|---|---|
Solid Tumor |
Drug: CHR-3996 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I Study to Evaluate the Safety and Tolerability of the Histone Deacetylase Inhibitor, CHR-3996, in Patients With Advanced Solid Tumours |
Estimated Enrollment: | 36 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Oral, once daily administration of CHR-3996 to determine safety and tolerability
|
Drug: CHR-3996
Once daily oral ingestion of capsules (5, 10 or 20 mg), dose depending on cohort, treatment cycle of 28 days
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Adequate bone marrow, hepatic and renal function including the following
EXCLUSION CRITERIA:
Patients with significant cardiovascular disease as defined by:
Contact: Sigrid Gruijs | 31-020-301-8520 | sgruijs@INCResearch.com |
Netherlands | |
Erasmus MC University Medical Center - Location Centrum | Recruiting |
Rotterdam, Netherlands, 3015 CE | |
Principal Investigator: F ALM Eskens, Dr | |
Erasmus University Medical Center - Location Daniel den Hoed | Recruiting |
Rotterdam, Netherlands, 3075 EA | |
Sub-Investigator: Maja De Jonge, Dr | |
United Kingdom, Surrey | |
The Royal Marsden Hospital | Recruiting |
Sutton, Surrey, United Kingdom, SM2 5PT | |
Principal Investigator: Udai Banerji, Dr |
Principal Investigator: | F ALM Eskens, Dr | Erasmus MC University Medical Center |
Principal Investigator: | Udai Banerji, Dr | The Royal Marsden Hospital |
Responsible Party: | Chroma Therapeutics ( Dr Leon Hooftman, Chief Medical Officer ) |
Study ID Numbers: | CHR-3996-001, EudraCT Number: 2007-005043-19 |
Study First Received: | June 10, 2008 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00697879 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
tumour Solid tumour histone deacetylase inhibitor dose escalation cancer |