Polycythemia VeraPhase 2NCT00866762
A Study of the Efficacy of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia
A Phase 2 study testing HDAC inhibitor (MK-0683) in people with Polycythemia Vera and Essential Thrombocythemia, run by Copenhagen University Hospital at Herlev at 16 sites in 4 countries.
Trial summary
The aim of the present study is to evaluate the efficacy and safety of MK-0683 in the treatment of PV and ET. This agent has most recently been shown to be a potent inhibitor of the autonomous proliferation of haematopoietic cells of PV and ET patients carrying the JAK2 V617F mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera, Essential Thrombocythemia
- What is being tested?
- HDAC inhibitor (MK-0683)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 16 sitesin 4 countries
- Study dates
- Feb 2009to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient > 18 years of age AND
- 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
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- 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)
Who cannot join
- A platelet count > 1500 x 10^9/L (a need for cytoreduction in platelet count)
- 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
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- 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.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
Denmark6 sites
Copenhagen University Hospital Rigshospitalet
Copenhagen, DK-2100
Esberg Hospital
Esbjerg, DK-6700
Herlev Hospital
Herlev, DK-2730
Odense University Hospital
Odense, DK-5000
Roskilde Hospital
Roskilde, DK-4000
Regional Hospital Viborg
Viborg, DK-8800
Sweden5 sites
University Hospital Orebro
Örebro, S-70185
Stockholm South General Hospital (Sodersjukhuset)
Stockholm, S-11883
Karolinska University Hospital Huddinge
Stockholm, S-14186
Sahlgrenska University Hospital & Uddevalla Hospital
Uddevalla, S-45180
Uppsala University Hospital
Uppsala, S-75185
United Kingdom4 sites
Centre for Cancer Research and Cell Biology, Queen's University Belfast
Belfast, Northern Ireland, BT9 7AB
Cardiff University
Cardiff, CF14 4XN
Russell's Hall Hospital
Dudley, DY1 2HQ
St Thomas' Hospital
London, SE1 7EH
About this study
Official title: A Phase II Study of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia.
The aim of the present study is to evaluate the efficacy and safety of MK-0683 in the treatment of PV and ET. This agent has most recently been shown to be a potent inhibitor of the autonomous proliferation of haematopoietic cells of PV and ET patients carrying the JAK2 V617F mutation. Accordingly, it may be anticipated that MK-0683 - by decreasing the JAK2 allele burden - may influence clonal myeloproliferation and in vivo granulocyte, platelet and endothelial activation , which are considered to be major determinants of morbidity and mortality ( thrombosis, bleeding, extramedullary haematopoiesis , myelofibrosis ) in these disorders. The effects of MK-0683 at the molecular level will be studied by global/ focused gene expression profiling, epigenome profiling and proteomics.
- Conditions
- Polycythemia Vera, Essential Thrombocythemia
- Being tested
- HDAC inhibitor (MK-0683)
- Keywords
- Polycythaemia Vera, Polycythemia Vera, Essential Thrombocythaemia, Essential Thrombocythemia, HDAC-inhibitor, Haematology, Hematology, Haematological disorder, Haematological disease, Hematological disorder, Hematological disease
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential, Polycythemia, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDAC inhibitor (MK-0683)Drug
400 mg once daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment with study drug approximately 6 months and follow-up for 3 months Receives: Drug: HDAC inhibitor (MK-0683) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of study drug (MK-0683) in the treatment of patients with PV and ET.
Measured: one year
Secondary outcomes (1)
To study changes in bone marrow morphology before and after treatment with study drug.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans C Hasselbalch, MD, Principal investigator, Department of Hematology, Copenhagen University Hospital Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866762
- Sponsor's protocol ID
- MK-0683/092-0
- Status last verified
- Dec 2011
- First submitted
- 17 Mar 2009
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of MK-0683 in Patients With Polycythaemia Vera and Essential Thrombocythaemia.
- ClinicalTrials.gov ID
- NCT00866762
- Acronym / sponsor ID
- MK-0683/092-0
- Conditions
- Polycythemia Vera, Essential Thrombocythemia
- Keywords
- Polycythaemia Vera, Polycythemia Vera, Essential Thrombocythaemia, Essential Thrombocythemia, HDAC-inhibitor, Haematology, Hematology, Haematological disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to evaluate the efficacy and safety of MK-0683 in the treatment of PV and ET. This agent has most recently been shown to be a potent inhibitor of the autonomous proliferation of haematopoietic cells of PV and ET patients carrying the JAK2 V617F mutation. Accordingly, it may be anticipated that MK-0683 - by decreasing the JAK2 allele burden - may influence clonal myeloproliferation and in vivo granulocyte, platelet and endothelial activation , which are considered to be major determinants of morbidity and mortality ( thrombosis, bleeding, extramedullary haematopoiesis , myelofibrosis ) in these disorders. The effects of MK-0683 at the molecular level will be studied by global/ focused gene expression profiling, epigenome profiling and proteomics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: HDAC inhibitor (MK-0683)Treatment with study drug approximately 6 months and follow-up for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female patient > 18 years of age AND
- A confirmed diagnosis of PV AND
- Biochemical evidence of active disease as defined by:
- Male or female patient > 18 years of age AND
- A confirmed diagnosis of ET AND
Key exclusion criteria (17 listed)
- A platelet count > 1500 x 10^9/L (a need for cytoreduction in platelet count)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDAC inhibitor (MK-0683)400 mg once daily for 6 months | Drug | 1 |
Primary outcome
To evaluate the efficacy of study drug (MK-0683) in the treatment of patients with PV and ET.
Time frame: one year
1 secondary outcome
To study changes in bone marrow morphology before and after treatment with study drug.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
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Active, not recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans C Hasselbalch, MD principal investigator
Department of Hematology, Copenhagen University Hospital Herlev
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDAC inhibitor (MK-0683) in people with Polycythemia Vera and Essential Thrombocythemia, run by Copenhagen University Hospital at Herlev at 16 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Denmark, Sweden, United Kingdom, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of study drug (MK-0683) in the treatment of patients with PV and ET. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2011.