Safety and Tolerability of CHR-2845 to Treat Haematological Diseases or Lymphoid Malignancies (CHR-2845-001)
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ClinicalTrials.gov Identifier: NCT00820508 |
Recruitment Status :
Completed
First Posted : January 12, 2009
Last Update Posted : November 28, 2011
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Condition or disease | Intervention/treatment | Phase |
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Hematological Disease Lymphoid Malignancies | Drug: CHR-2845 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |
Arm | Intervention/treatment |
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Experimental: 1
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 |
- To determine the safety, tolerability, dose-limiting toxicities (DLT), maximum acceptable dose (MAD) and maximum tolerated dose (MTD) [ Time Frame: 28 days ]
- To determine pharmacokinetic parameters of CHR-2845 and the active metabolite CHR-2847 [ Time Frame: days 1 and 28 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed, informed consent
- Confirmed malignant haematological disease or lymphoid malignancy refractory to standard therapy or for which no standard therapy exists, including acute leukemias, MDS, CML, CLL, CMML, multiple myeloma and Non-Hodgkin's Lymphomas/Hodgkin's disease
- Patients shall have recovered from all acute adverse effects of prior therapies, with the exception of alopecia and grade 1 neuropathy where recovery is not required
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Adequate bone marrow, hepatic and renal function including the following:
- Patients with high blast counts can be included if they can be controlled by the use of hydroxyurea (500 mg -3,000 mg daily).
- Total bilirubin ≤ 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilbert's Syndrome
- AST (SGOT), ALT (SGPT) ≤ 2.5 x upper normal limit
- Creatinine ≤ 1.5 x upper normal limit
- Age ≥ 18 years
- Performance status (PS) ≤ 2 - Eastern Cooperative Oncology Group (ECOG) scale
- Estimated life expectancy greater than 3 months
- Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment.
Exclusion Criteria:
- Patients receiving anti-cancer therapy or use of other investigational agents within 21 days prior to trial entry (or a longer period depending on the defined characteristics of the agents used. Bisphosphonates for bone disease and corticosteroids are permitted provided the dose does not change during the trial. Patients must have recovered from all transient toxicity induced by prior therapy
- Patients with co-existing active infection, graft versus host disease or serious concurrent illness
- Patients who have failed to recover from or after a bone marrow transplantation or haematopoietic stem cell transplantation
- The following diseases are excluded: Burkitt's lymphoma, primary effusion lymphoma, precursor B-cell lymphoblastic lymphoma, symptomatic central nervous system (CNS) lymphoma, CML blast crisis
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Patients with significant cardiovascular disease as defined by:
- history of congestive heart failure requiring therapy
- history of angina pectoris requiring treatment or myocardial infarction within 6 months prior to trial entry
- presence of severe valvular heart disease
- presence of an atrial or ventricular arrhythmia requiring treatment
- Left Ventricular Ejection Fraction (LVEF) below the normal range at the study centre
- Uncontrolled hypertension
- A history of abnormal QTc intervals or an average QTc interval at screening ≥450 msec
- Any medical or other condition that in the investigator's opinion renders the patient unsuitable for this study due to unacceptable risk
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
- Gastrointestinal disorders that may interfere with absorption of the study drug
- Patients with known brain tumours or metastases
- More than 6 prior chemotherapy regimens
- Patients requiring growth factor support (erythropoietin, Granulocyte/monocyte Colony Stimulating Factor (GM/CSF), etc)
- Patients requiring palliative radiotherapy within the last 4 weeks prior to study entry
- Uncontrolled hypercalcaemia (CTCAE v3 grade 2 or higher)
- Abnormal plasma potassium or magnesium levels (Common Terminology Criteria for Adverse Events (CTCAE) v3 grade 3 or greater) despite therapy
- Pregnant or breast-feeding women

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820508
Belgium | |
ZNA Stuivenberg | |
Antwerp, Belgium, 2060 | |
France | |
Institut Paoli-Calmettes | |
Marseille, France | |
Netherlands | |
VU University Medical Center | |
Amsterdam, Netherlands, 1007 MB | |
Erasmus University Medical Center | |
Rotterdam, Netherlands, 3015 CE |
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: | Norbert Vey, MD | Institut Paoli-Calmettes |
Responsible Party: | Chroma Therapeutics |
ClinicalTrials.gov Identifier: | NCT00820508 |
Other Study ID Numbers: |
CHR-2845-001 |
First Posted: | January 12, 2009 Key Record Dates |
Last Update Posted: | November 28, 2011 |
Last Verified: | November 2011 |
Haematological disease Lymphoid malignancy Histone deacetylase inhibitor dose escalation |
Neoplasms Hematologic Diseases |