Polycythemia VeraPhase 2NCT00586651
Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis
A Phase 2 study testing lestaurtinib in people with Polycythemia Vera and Essential Thrombocytosis, run by Cephalon at 4 sites in United States.
Trial summary
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with Essential Thrombocytosis (ET). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Polycythemia Vera, Essential Thrombocytosis
- What is being tested?
- lestaurtinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2007to Sep 2010
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has polycythemia vera (PV) or essential thrombocytosis (ET).
- The patient has a detectable JAK2 V617F mutation.
- Patients with PV have at least 1 of the following risk factors:
- neutrophil count greater than 7000/mm3
- receiving hydroxyurea treatment
- Patients with ET are receiving concomitant hydroxyurea.
- The patient has an ECOG performance score of 0, 1, or 2.
Who cannot join
- The patient has bilirubin levels or aspartate transaminases (AST) levels within exclusionary ranges.
- patient has serum creatinine concentrations within exclusionary ranges.
- patient has an untreated or progressive infection.
- patient has any physical or psychiatric condition that may compromise participation in the study.
- has a history of venous or arterial thrombosis within 6 months.
- use of hydroxyurea has been initiated or escalated in the month prior to screening.
Show all 12Show fewer
- has active gastrointestinal ulceration or bleeding.
- patient has used an investigational drug within the past 30 days.
- patient is being treated with anagrelide.
- patient has previously taken CEP-701 (lestaurtinib).
- patient has hypersensitivity to CEP-701 (lestaurtinib) or any component of CEP-701 (lestaurtinib).
- patient has received interferon within the past 30 days.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University
Baltimore, Maryland, 21231
NY Presbyterian-Cornell
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10128
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with Essential Thrombocytosis (ET).
Read the detailed description
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment at a dosage of 80 mg bid for 18 weeks (126 days) in patients with Polycythemia Vera (PV) who have abnormal baseline neutrophil counts or require hydroxyurea therapy and patients with Essential Thrombocytosis (ET) who require hydroxyurea therapy for disease control.
- Conditions
- Polycythemia Vera, Essential Thrombocytosis
- Being tested
- lestaurtinib
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lestaurtinibDrug
60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration
| Study group | Role | What they receive |
|---|---|---|
| lestaurtinib | Experimental | Not described Receives: Drug: lestaurtinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.
Measured: 18 weeks +
Secondary outcomes (1)
- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy
Measured: 18 weeks +
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586651
- Sponsor's protocol ID
- C0701/2030/ON/US
- Status last verified
- Sep 2015
- First submitted
- 21 Dec 2007
- Last updated
- 8 Oct 2015
- Results posted
- No
Publications
Hexner E, Roboz G, Hoffman R, Luger S, Mascarenhas J, Carroll M, Clementi R, Bensen-Kennedy D, Moliterno A. Open-label study of oral CEP-701 (lestaurtinib) in patients with polycythaemia vera or essential thrombocythaemia with JAK2-V617F mutation. Br J Haematol. 2014 Jan;164(1):83-93. doi: 10.1111/bjh.12607. Epub 2013 Oct 28.
PubMed 24903629
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation
- ClinicalTrials.gov ID
- NCT00586651
- Acronym / sponsor ID
- C0701/2030/ON/US
- Conditions
- Polycythemia Vera, Essential Thrombocytosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Jan 2008 (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.
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with Essential Thrombocytosis (ET).
Detailed description
This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment at a dosage of 80 mg bid for 18 weeks (126 days) in patients with Polycythemia Vera (PV) who have abnormal baseline neutrophil counts or require hydroxyurea therapy and patients with Essential Thrombocytosis (ET) who require hydroxyurea therapy for disease control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lestaurtinib | Experimental | Drug: lestaurtinib |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient has polycythemia vera (PV) or essential thrombocytosis (ET).
- The patient has a detectable JAK2 V617F mutation.
- Patients with PV have at least 1 of the following risk factors:
- Patients with ET are receiving concomitant hydroxyurea.
- The patient has an ECOG performance score of 0, 1, or 2.
Key exclusion criteria (12 listed)
- The patient has bilirubin levels or aspartate transaminases (AST) levels within exclusionary ranges.
- patient has serum creatinine concentrations within exclusionary ranges.
- patient has an untreated or progressive infection.
- patient has any physical or psychiatric condition that may compromise participation in the study.
- has a history of venous or arterial thrombosis within 6 months.
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 |
|---|---|---|
| lestaurtinib60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration | Drug | lestaurtinib |
Primary outcome
Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.
Time frame: 18 weeks +
1 secondary outcome
- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy
Time frame: 18 weeks +
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Derived from this study: PubMed 24903629Hexner E, Roboz G, Hoffman R, Luger S, Mascarenhas J, Carroll M, Clementi R, Bensen-Kennedy D, Moliterno A. Open-label study of oral CEP-701 (lestaurtinib) in patients with polycythaemia vera or essential thrombocythaemia with JAK2-V617F mutation. Br J Haematol. 2014 Jan;164(1):83-93. doi: 10.1111/bjh.12607. Epub 2013 Oct 28.
Related trials for Polycythemia Vera
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 2/3
A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025).
Polycythemia Vera
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 2
A Study of Ropeg-Interferon in People With Polycythemia Vera
Polycythemia Vera (PV), JAK2 Mutation
Active, not recruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Polycythemia Vera (PV)
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lestaurtinib in people with Polycythemia Vera and Essential Thrombocytosis, run by Cephalon at 4 sites in United States.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study. (time frame: 18 weeks +). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00586651, which also lists 1 linked publication.
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 8 Oct 2015.