A Study of the Efficacy of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia
NCT ID: NCT00866762
Last Updated: 2011-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2009-02-28
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Treatment with study drug approximately 6 months and follow-up for 3 months
HDAC inhibitor (MK-0683)
400 mg once daily for 6 months
Interventions
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HDAC inhibitor (MK-0683)
400 mg once daily for 6 months
Eligibility Criteria
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Inclusion Criteria
* A confirmed diagnosis of PV AND
* Biochemical evidence of active disease as defined by:
* a need for phlebotomy within last 3 months
* a leukocyte count \> 10 x 10\^9/L in the absence of infection or inflammation (normal CRP) and/or (PV/ET)
* a platelet count \> 450 x 10\^9/L in the absence of infection or inflammation (normal CRP)(PV/ET) OR
* Male or female patient \> 18 years of age AND
* A confirmed diagnosis of ET AND
* Biochemical evidence of active disease as defined by \*a platelet count \> 450 x 10\^9/L in the absence of infection or inflammation
* Newly diagnosed or previously treated patient in chronic phase OR
* Advanced phase PV or ET as defined by blasts of \> 1 x 10\^9/L in the peripheral blood and/or white cell count \> 30 x 10\^9/L OR
* Resistant or refractory PV or ET as defined by haemoglobin \< 10.5 gm/dl with a platelet count \> 600 x 10\^9/L on current therapy OR
* Cycling platelet counts on therapy OR
* Intolerant to other therapies defined by patients with PV or ET who have side effects on current therapies preventing continuation (leg ulcers on hydroxycarbamide, unacceptable fatigue etc on interferon)
Exclusion Criteria
* Patients of childbearing potential without a negative pregnancy test prior to initiation of study drug
* Women who are breast feeding
* Males and females not using contraceptives if sexually active.
* EGOC Performance status Score \> or = 3
* Serum creatinine more than 2 x's teh ULN
* Total serum bilirubin more than 1.5 x's the ULN
* Serum AST/ALT more than 3 x's the ULN
* Interferon alpha within 1 week of day 1
* Hydroxycarbamide within 1 week of day 1
* Anagrelide within 1 week of day 1
* Valproic acid (as an anticonvulsant) within 28 days of day 1
* Any other investigational drug within 28 days of day 1
* Active HIV, HBV or HCV infection
* Any serious concomitant disease or circumstances that could limit compliance with the study, including but not limited to the following: CTCAE grade 3-4 cardiac general \& arrhythmia, or psychiatric or social conditions that may interfere with patient compliance.
* Any prior malignancy with the exception of cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or other localized malignancy that has undergone potentially curative therapy with no evidence of that disease for five years, and who is deemed to be at low risk for recurrence by his/her treating physician.
* Patient has a known allergy or hypersensitivity to study drug.
18 Years
ALL
No
Sponsors
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Copenhagen University Hospital at Herlev
OTHER
Responsible Party
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Principal Investigators
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Hans C Hasselbalch, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Hematology, Copenhagen University Hospital Herlev
Locations
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Copenhagen University Hospital Rigshospitalet
Copenhagen, , Denmark
Esberg Hospital
Esbjerg, , Denmark
Herlev Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Roskilde Hospital
Roskilde, , Denmark
Regional Hospital Viborg
Viborg, , Denmark
VU University Medical Centre
Amsterdam, , Netherlands
University Hospital Orebro
Örebro, , Sweden
Stockholm South General Hospital (Sodersjukhuset)
Stockholm, , Sweden
Karolinska University Hospital Huddinge
Stockholm, , Sweden
Sahlgrenska University Hospital & Uddevalla Hospital
Uddevalla, , Sweden
Uppsala University Hospital
Uppsala, , Sweden
Centre for Cancer Research and Cell Biology, Queen's University Belfast
Belfast, Northern Ireland, United Kingdom
Cardiff University
Cardiff, , United Kingdom
Russell's Hall Hospital
Dudley, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
Countries
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Other Identifiers
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MK-0683/092-0
Identifier Type: -
Identifier Source: org_study_id