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Sponsored by: |
Chroma Therapeutics |
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Information provided by: | Chroma Therapeutics |
ClinicalTrials.gov Identifier: | NCT00820508 |
The purpose of this study is to determine whether the histone deacetylase inhibitor CHR-2845 is tolerated in patients with haematological diseases and lymphoid malignancies.
Condition | Intervention | Phase |
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Hematological Disease Lymphoid Malignancies |
Drug: CHR-2845 |
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-2845, in Patients With Advanced or Treatment Refractory Haematological Diseases or Lymphoid Malignancies |
Estimated Enrollment: | 36 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Oral, once daily administration of CHR-2845 to determine safety and tolerability
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Drug: CHR-2845
Once daily oral ingestion of capsules (10, 40 or 80mg), dose depending on cohort, treatment cycle of 28 days
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CHR-2845 is a novel type of histone deacetylase inhibitor (HDACi) for use in cancer that, in addition to having broad ranging anti-proliferative activity against transformed cells, is designed to have an increased therapeutic window against diseases which involve cells of the monocyte-macrophage lineage. There are several HDACi's in clinical development and one, SAHA (Vorinostat, Zolinza®), has recently been approved for use in the treatment of cutaneous T-cell lymphoma. CHR-2845 is a cell-permeant ester that is metabolised to give an active acid, CHR-2847, which selectively accumulates in monocytes and macrophages. This results in a 20-100 fold increase in anti-proliferative potency of CHR-2845 for monocytic over non-monocytic tumour cells. This selectivity should lead to an increased therapeutic window in haematological malignancies involving cells of the monocyte lineage (AML M4, AML M5 and CMML). In addition, there is increasing evidence that monocytes and macrophages associated with some haematological tumours (tumour-associated macrophages (TAMs)) are involved in supporting the growth and spread of the tumour. This clinical trial will focus on haematological and lymphoid malignancies with the intention of evaluating the safety and tolerability of CHR-2845. Additionally it will compare response in patients where monocytes/macrophages are important disease drivers, with the response in other patients. This will allow an early determination of the potential improvement in therapeutic window afforded by the monocyte/macrophage directed HDACi activity.
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: Yulia Youmatova, M.D | +44 (0) 1628583206 | yyoumatova@incresearch.com |
Belgium | |
ZNA Stuivenberg | Recruiting |
Antwerp, Belgium, 2060 | |
Principal Investigator: Pierre Zachee, MD | |
France, St-Herblain-Cdx | |
Centre René GAUDUCHEAU | Not yet recruiting |
Nantes, St-Herblain-Cdx, France, 44 805 | |
Principal Investigator: Jean L Harousseau, MD | |
Netherlands | |
Erasmus University Medical Center | Not yet recruiting |
Rotterdam, Netherlands, 3015 CE | |
Principal Investigator: Bob Löwenberg, M.D | |
VU University Medical Center | Not yet recruiting |
Amsterdam, Netherlands, 1007 MB | |
Principal Investigator: Gert Ossenkoppele, M.D |
Principal Investigator: | Bob Löwenberg, M.D | Erasmus Medical Center |
Principal Investigator: | Gert Ossenkoppele, M.D | VU University Medical Center |
Principal Investigator: | Pierre Zachee, MD | ZNA Stuivenberg |
Principal Investigator: | Jean L harousseau, MD | Centre René Gauducheau |
Principal Investigator: | Norbert Vey, MD | Institut Paoli-calmettes |
Responsible Party: | Chroma Therapeutics ( Dr Leon Hooftman, Chief Medical Officer ) |
Study ID Numbers: | CHR-2845-001 |
Study First Received: | January 9, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00820508 |
Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products; France: Afssaps - French Health Products Safety Agency; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Haematological disease Lymphoid malignancy Histone deacetylase inhibitor dose escalation |
Hematologic Diseases |
Neoplasms |