Polycythemia VeraPhase 2NCT00538980
Dasatinib in Polycythemia Vera
A Phase 2 study testing Dasatinib in people with Polycythemia Vera, run by Weill Medical College of Cornell University at 4 sites in United States.
Trial summary
The purpose for conducting this research study is to determine the feasibility of using dasatinib as a treatment for polycythemia vera and to determine the optimum treatment regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- Dasatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Apr 2007to 27 Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients must be >= 18 years old
- Performance Status (ECOG) 0-3
- Previous therapies limited to interferon-alpha, hydroxyurea, anagrelide, and imatinib
- Patients may have documented resistance or intolerance to interferon-alpha, imatinib, hydroxyurea, or anagrelide, but must have been demonstrated to be phlebotomy dependent requiring 6 or more phlebotomies per year to maintain the target HCT.
- Patients may have newly diagnosed PV.
- Patients may have had inadequate phlebotomy control on hydroxyurea or imatinib.
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- Adequate Organ Function
- Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
- Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN
- Serum Na, K+, Mg2+, Phosphate and Ca2+³ Lower Limit of Normal (LLN)
- Serum Creatinine < 1.5 time the institutional ULN
- Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0-1
- Ability to take oral medication: dasatinib tablets may be swallowed whole, or may be ingested as a solution. Dasatinib tablets can be dissolved in juice, and can then be administered through a nasogastric tube.
- Women of childbearing potential (WOCBP) must have:
- A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration
- Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped.
- Signed written informed consent including HIPAA according to institutional guidelines
Who cannot join
- Patients receiving busulfan within six weeks of Study Day 1.
- Patients receiving treatment with interferon-alpha within 4 weeks of Study Day 1.
- Patients receiving treatment with imatinib within 14 days of Study, Day 1.
- Patients with Grade 3 or 4 cardiac problems as defined by the New York Heart Association Criteria.
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
- A malignancy [other than the one treated in this study], which required radiotherapy or systemic treatment within the past 5 years.
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- Concurrent medical condition which may increase the risk of toxicity, including:
- Pleural or pericardial effusion of any grade
- Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)
- Cardiac Symptoms, consider the following:
- Uncontrolled angina, congestive heart failure or MI within (6 months)
- Diagnosed congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
- Subjects with hypokalemia or hypomagnesemia if it cannot be corrected
- History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
- Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding
- Concomitant Medications, consider the following prohibitions:
- Drugs that are generally expected to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
- The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy.
- Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy
- Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
- Patient may not be receiving any prohibited CYP3A4 inhibitors
- Women:
- Unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or
- Have a positive pregnancy test at baseline, or
- Are pregnant or breastfeeding
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
The Jones Clinic
Germantown, Tennessee, 38138
Hematology/Oncology Associates of Rockland
New City, New York, 10956
Weill Cornell Medical College - New York Presbyterian Hospital
New York, New York, 10021
About this study
Official title: A Phase II, Non-Randomized Study of the Use of Desatinib (Sprycel) in Treating Patients With Polycythemia Vera (PV) BMS Protocol Number: CA180-104
The purpose for conducting this research study is to determine the feasibility of using dasatinib as a treatment for polycythemia vera and to determine the optimum treatment regimen.
- Conditions
- Polycythemia Vera
- Being tested
- Dasatinib
- Keywords
- Polycythemia Vera, PV, P Vera
- Medical subject headings
- Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DasatinibDrug
Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day). Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range
To evaluate the effect of dasatinib on the platelet count and the stabilization of hematocrit when restored by phlebotomy to normal range (HCT <45% for men, <42% for women). Analysis was not completed because the study was terminated early due to lack of efficacy.
Measured: Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.
Change in Performance Status and Development of Side Effects and Complications
To determine change in performance status and development of side effects and complications in patients treated under this protocol. Analysis was not completed because the study was terminated early due to lack of efficacy.
Measured: Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter.
Secondary outcomes (3)
Changes in Marrow Cellularity, Reticulin and Fibrous Content
To determine changes in marrow cellularity, reticulin and fibrous content. Analysis was not completed because the study was terminated early due to lack of efficacy.
Measured: Bone marrow analysis will be performed at baseline and month 6.
Change in Cytogenetics
To determine change in cytogenetics if initially abnormal. Analysis was not completed because the study was terminated early due to lack of efficacy.
Measured: Cytogenetics analysis will be performed at baseline and month 6.
Change in JAK2 Allele Burden
To determine if quantitative change in JAK2 expression occurs as measured by quantitative pyrosequencing. Analysis was not completed because the study was terminated early due to lack of efficacy.
Measured: JAK2 analysis will be performed at baseline and month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2007 (estimated)
- Study start30 Apr 2007
- Primary completion25 Aug 2010
- Study completion27 Aug 2010
Why it stopped: This study was terminated due to lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Richard T Slver, M.D., Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538980
- Sponsor's protocol ID
- 0701008940
- Other IDs
- CA180-104
- Status last verified
- May 2017
- First submitted
- 2 Oct 2007
- Last updated
- 20 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Non-Randomized Study of the Use of Desatinib (Sprycel) in Treating Patients With Polycythemia Vera (PV) BMS Protocol Number: CA180-104
- ClinicalTrials.gov ID
- NCT00538980
- Acronym / sponsor ID
- 0701008940
- Conditions
- Polycythemia Vera
- Keywords
- Polycythemia Vera, PV, P Vera
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to lack of efficacy.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 30 Apr 2007 (actual)
- Primary completion
- 25 Aug 2010 (actual)
- Study completion
- 27 Aug 2010 (actual)
- First posted
- 3 Oct 2007 (estimated)
- Results
- Posted 20 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose for conducting this research study is to determine the feasibility of using dasatinib as a treatment for polycythemia vera and to determine the optimum treatment regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Drug: DasatinibPatients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must be >= 18 years old
- Performance Status (ECOG) 0-3
- Previous therapies limited to interferon-alpha, hydroxyurea, anagrelide, and imatinib
- Patients may have documented resistance or intolerance to interferon-alpha, imatinib, hydroxyurea, or anagrelide, but must have been demonstrated to be phlebotomy dependent requiring 6 or more phlebotomies per year to maintain the target HCT.
- Patients may have newly diagnosed PV.
Key exclusion criteria (29 listed)
- Patients receiving busulfan within six weeks of Study Day 1.
- Patients receiving treatment with interferon-alpha within 4 weeks of Study Day 1.
- Patients receiving treatment with imatinib within 14 days of Study, Day 1.
- Patients with Grade 3 or 4 cardiac problems as defined by the New York Heart Association Criteria.
- Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
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 |
|---|---|---|
| DasatinibPatients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day). | Drug | All patients |
Primary outcome
Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range
Time frame: Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.
To evaluate the effect of dasatinib on the platelet count and the stabilization of hematocrit when restored by phlebotomy to normal range (HCT <45% for men, <42% for women). Analysis was not completed because the study was terminated early due to lack of efficacy.
Change in Performance Status and Development of Side Effects and Complications
Time frame: Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter.
To determine change in performance status and development of side effects and complications in patients treated under this protocol. Analysis was not completed because the study was terminated early due to lack of efficacy.
3 secondary outcomes
Changes in Marrow Cellularity, Reticulin and Fibrous Content
Time frame: Bone marrow analysis will be performed at baseline and month 6.
Change in Cytogenetics
Time frame: Cytogenetics analysis will be performed at baseline and month 6.
Change in JAK2 Allele Burden
Time frame: JAK2 analysis will be performed at baseline and month 3.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard T Slver, M.D. principal investigator
Weill Medical College of Cornell University
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 Dasatinib in people with Polycythemia Vera, run by Weill Medical College of Cornell University 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 17 inclusion and 29 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: stopped early, as of the sponsor's last update on 20 Jun 2017. 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?
Yes. Results are posted in the registry (first posted 20 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of Dasatinib on the Platelet Count and the Stabilization of Hematocrit When Restored by Phlebotomy to Normal Range (time frame: Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter.). The study lists 2 primary outcomes in all. 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 20 Jun 2017.