Hematopoietic NeoplasmPhase 2NCT01420783
Study With SAR302503 in Patients With Polycythemia Vera or Essential Thrombocythemia
A Phase 2 study testing SAR302503 in people with Hematopoietic Neoplasm, run by Bristol-Myers Squibb at 35 sites in 9 countries.
Trial summary
Primary Objective: Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for : Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Neoplasm
- What is being tested?
- SAR302503
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 35 sitesin 9 countries
- Study dates
- Oct 2011to May 2014
- 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
- Has had a diagnosis of hydroxyurea resistant or intolerant polycythemia vera (PV) or essential thrombocythemia (ET) documented at Screening.
- Polycythemia vera or essential thrombocythemia defined according to the revised WHO criteria.
- Polycythemia vera resistance or intolerance to hydroxyurea is defined as polycythemia vera patients on hydroxyurea with a hematocrit >45%, or phlebotomy twice in the last 6 months and at least once in the last 3 months.
- Essential thrombocythemia resistance or intolerance to hydroxurea is defined as essential thrombocythemia patients on HU with platelet count >600 x 10x9/L.
- Dose Expansion Phase (polycythemia vera) and 600 mg/day group (essential thrombocythemia):
- Has had a diagnosis of polycythemia vera or essential thrombocythemia according to the revised WHO 2008 criteria.
Show all 9Show fewer
- PV patients must be resistant or intolerant to hydroxyurea.
- ET patients must be resistant or intolerant to hydroxyurea.
- Provide written informed consent to participate.
Who cannot join
- Less than 18 years of age.
- Participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase. (Prior treatment with another JAK2 inhibitor is allowed.)
- Unwilling to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 or 4 at study entry.
- Splenectomy.
- Active malignancy other than polycythemia vera or essential thrombocythemia, except adequately treated basal cell carcinoma and squamous cell carcinoma of the skin, cervical carcinoma in situ, or other malignancies that have been stable and off therapy for ≥5 years.
Show all 20Show fewer
- Major surgery within 28 days or radiation within 3 months prior to initiation of study drug.
- Active acute infection requiring antibiotics.
- Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.
- Any severe acute or chronic medical, neurological, or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with interpretation of study results and, in the Investigator's opinion, would make the patient inappropriate for entry into this study.
- Inadequate organ function.
- Known active (acute or chronic) Hepatitis A, B, or C; and Hepatitis B and C carriers.
- Prior history of chronic liver disease (eg, chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemachromatosis, non-alcoholic steatohepatitis [NASH]).
- Concomitant treatment with or use of drugs or herbal agents known to be at least moderate inhibitors or inducers cytochrome P450 3A4 (CYP3A4).
- Presence of any gastric or other disorder that would inhibit absorption of oral medication.
- Known hypersensitivity to any excipients in the study drug formulation.
- Women of childbearing potential, unless using effective contraception while on study drug.
- Men who partner with a woman of childbearing potential, unless they agree to use effective contraception while on study drug.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
35 sites in 9 countries.
35 sites in 9 countries
United States8 sites
Investigational Site Number 840010
Ann Arbor, Michigan, 48109-0759
Investigational Site Number 840001
Houston, Texas, 77030
Investigational Site Number 840004
La Jolla, California, 92093
Investigational Site Number 840005
Los Angeles, California, 90033
Investigational Site Number 840011
Palo Alto, California, 94301
Investigational Site Number 840007
Rochester, Minnesota, 55905
Investigational Site Number 840008
Scottsdale, Arizona, 85259-5499
Investigational Site Number 840003
St Louis, Missouri, 63110
Australia4 sites
Investigational Site Number 036001
Clayton, 3168
Investigational Site Number 036002
Kingswood, 2747
Investigational Site Number 036004
Kogarah, 2217
Investigational Site Number 036003
Randwick, 2031
South Korea4 sites
Investigational Site Number 410001
Seongnam, 463-707
Investigational Site Number 410003
Seoul, 110-744
Investigational Site Number 410004
Seoul, 120-752
Investigational Site Number 410002
Seoul, 135-710
Spain4 sites
Investigational Site Number 724004
Badalona, 08916
Investigational Site Number 724001
Barcelona, 08036
Investigational Site Number 724003
Madrid, 28046
Investigational Site Number 724002
Valencia
United Kingdom4 sites
Investigational Site Number 826001
Belfast, BT9 7AB
Investigational Site Number 826006
Birmingham, B9 5SS
Investigational Site Number 826003
London, SE1 7EH
Investigational Site Number 826004
London, W12 0HS
Canada3 sites
Investigational Site Number 124002
Montreal, H3T 1E2
Investigational Site Number 124003
Toronto, M5G 2M9
Investigational Site Number 124001
Vancouver, V6Z 1Y6
France3 sites
Investigational Site Number 250004
Brest, 29609
Investigational Site Number 250003
Marseille, 13273
Investigational Site Number 250001
Paris, 75475
Italy3 sites
Investigational Site Number 380003
Bologna, 40138
Investigational Site Number 380001
Florence, 50134
Investigational Site Number 380004
Orbassano, 10043
Germany2 sites
Investigational Site Number 276004
Frankfurt am Main, 60590
Investigational Site Number 276003
Mannheim, 68167
About this study
Official title: A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to Hydroxyurea
Primary Objective:
- Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for :
- Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and
- Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients with essential thrombocythemia.
- PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for:
- Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with PV, and
- Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with ET.
Read more
Secondary Objectives:
- To evaluate the safety of SAR302503.
- To evaluate the efficacy of SAR302503 in patients with PV who are resistant or intolerant to hydroxyurea for inducing absence of phlebotomy eligibility.
- To evaluate the efficacy of SAR302503 in patients with ET who are resistant or intolerant to hydroxyurea for reduction of platelet counts.
- To evaluate the efficacy of SAR302503 in inducing complete and partial responses beginning at Day 1 of Cycle 6 visit through Cycle 8.
- To evaluate splenic response as measured by spleen volume using MRI or CT.
- To evaluate the pharmacokinetics of SAR302503 after single and repeat doses.
- To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition.
- To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life.
- To measure generic health-related quality of life and utility value using the EuroQol Group (EQ-5DTM) questionnaire.
Read the detailed description
The duration of the study for an individual patient is at least 40 weeks and will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of up to 8, 28-day cycles (32 weeks), and a follow-up visit 30 days following the last administration of study drug. Treatment may continue if the patient is deriving benefit and does not experience disease progression, unacceptable toxicity, or meet other study withdrawal criteria.
Per Protocol Amendment No. 5, accrual of patients with essential thrombocythemia is closed.
- Conditions
- Hematopoietic Neoplasm
- Being tested
- SAR302503
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR302503Drug
Pharmaceutical form:capsule
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| SAR302503 100 mg | Experimental | once daily X 28 days Receives: Drug: SAR302503 |
| SAR302503 200 mg | Experimental | once daily X 28 days Receives: Drug: SAR302503 |
| SAR302503 400 mg | Experimental | once daily X 28 days Receives: Drug: SAR302503 |
| SAR302503 600 mg | Experimental | once daily X 28 days Receives: Drug: SAR302503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Ranging Phase: Proportion of PV patients with absence of phlebotomy and hematocrit below 45% and proportion of ET patients with a platelet count ≤ 400 x 10x9/L for a minimum of 3 months during the first 8 cycles of therapy.
Measured: 2 years
PV Dose Expansion Phase: Proportion of PV patients with absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit.
Measured: 2 years
ET Dose Ranging Phase (only 600 mg dose group): Proportion of ET patients with a platelet count ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit.
Measured: 2 years
Secondary outcomes (11)
Proportion of PV patients with absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit through Cycle 8 (for PV dose expansion phase only).
Measured: 2 years
Proportion of ET patients with platelet count ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Cycle 8.
Measured: 2 years
Characterization of clinicohematologic response (CR, PR, and no Response) defined by European LeukemiaNet beginning at Day 1 of Cycle 6 visit through Cycle 8.
Measured: 2 years
Percent change in spleen volume (per Magnetic Resonance Imaging (MRI)) at the end of Cycles 4 and 8 or end of treatment (EOT) relative to baseline.
Measured: 2 years
Proportion of patients with a ≥ 35% reduction in spleen volume (per Magnetic Resonance Imaging (MRI)) at the end of Cycles 4 and 8 or end of treatment (EOT) relative to baseline.
Measured: 2 years
Number of participants who have changes in histological, cytogenetic, and molecular responses in bone marrow.
Measured: 2 years
Response (defined as either a 2-point improvement in or resolution of a symptom present at baseline) at the end of Cycles 1, 4, and 8 or end of treatment (EOT), as measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF).
Measured: 2 years
Cumulative Distribution Function of responses between treatment groups at the end of Cycles 1, 4, and 8 or EOT on the MPN-SAF.
Measured: 2 years
For each MPN-associated symptom present at baseline on the MPN-SAF, proportion of patients with resolution of that symptom at the end of Cycles 1, 4, and 8.
Measured: 2 years
To measure generic health-related quality of life and utility values using the EQ-5D questionnaire after completion of 8 cycles of therapy.
Measured: 2 years
Characterization of the safety profile of SAR302503, including the frequency, duration, and severity of adverse events graded using the National Cancer Institute (NCI) - CTCAE version 4.03, clinical laboratory parameters, ECG, and vital signs.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2012
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic NeoplasmStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420783
- Sponsor's protocol ID
- ARD12042
- Other IDs
- 2011-001847-58, U1111-1121-4203
- Status last verified
- Feb 2016
- First submitted
- 11 Aug 2011
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II, Open-Label Study of the Efficacy and Safety of Orally Administered SAR302503 in Patients With Polycythemia Vera (PV) or Essential Thrombocythemia (ET) Who Are Resistant or Intolerant to Hydroxyurea
- ClinicalTrials.gov ID
- NCT01420783
- Acronym / sponsor ID
- ARD12042
- Conditions
- Hematopoietic Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Aug 2011 (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.
Primary Objective:
- Dose Ranging Phase: To evaluate the efficacy of daily oral doses of 100, 200, and 400 mg SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for :
- Inducing absence of phlebotomy and a hematocrit below 45% for a minimum of 3 months in patients with polycythemia vera, and
- Reduction of platelet count to ≤400 x 10x9/L for a minimum of 3 months in patients with essential thrombocythemia.
- PV Dose Expansion Phase and ET Dose Ranging Phase (only 600 mg dose group): To evaluate the efficacy of daily oral SAR302503 in patients with PV and ET who are resistant or intolerant to hydroxyurea (per European LeukemiaNet criteria) for:
- Inducing absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with PV, and
- Reduction of platelet count to ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit in patients with ET.
Secondary Objectives:
- To evaluate the safety of SAR302503.
- To evaluate the efficacy of SAR302503 in patients with PV who are resistant or intolerant to hydroxyurea for inducing absence of phlebotomy eligibility.
- To evaluate the efficacy of SAR302503 in patients with ET who are resistant or intolerant to hydroxyurea for reduction of platelet counts.
- To evaluate the efficacy of SAR302503 in inducing complete and partial responses beginning at Day 1 of Cycle 6 visit through Cycle 8.
- To evaluate splenic response as measured by spleen volume using MRI or CT.
- To evaluate the pharmacokinetics of SAR302503 after single and repeat doses.
- To evaluate the pharmacodynamics of SAR302503 as measured by changes in JAK2V617F allele burden in patients with JAK2V617F mutation, and STAT3 phosphorylation inhibition.
- To measure improvement in baseline myeloproliferative neoplasm (MPN)-associated symptoms, as well as overall impact on quality of life.
- To measure generic health-related quality of life and utility value using the EuroQol Group (EQ-5DTM) questionnaire.
Detailed description
The duration of the study for an individual patient is at least 40 weeks and will include a period to assess eligibility (screening period) of up to 4 weeks (28 days), a treatment period of up to 8, 28-day cycles (32 weeks), and a follow-up visit 30 days following the last administration of study drug. Treatment may continue if the patient is deriving benefit and does not experience disease progression, unacceptable toxicity, or meet other study withdrawal criteria.
Per Protocol Amendment No. 5, accrual of patients with essential thrombocythemia is closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SAR302503 100 mg | Experimental | Drug: SAR302503once daily X 28 days |
| SAR302503 200 mg | Experimental | Drug: SAR302503once daily X 28 days |
| SAR302503 400 mg | Experimental | Drug: SAR302503once daily X 28 days |
| SAR302503 600 mg | Experimental | Drug: SAR302503once daily X 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has had a diagnosis of hydroxyurea resistant or intolerant polycythemia vera (PV) or essential thrombocythemia (ET) documented at Screening.
- Polycythemia vera or essential thrombocythemia defined according to the revised WHO criteria.
- Polycythemia vera resistance or intolerance to hydroxyurea is defined as polycythemia vera patients on hydroxyurea with a hematocrit >45%, or phlebotomy twice in the last 6 months and at least once in the last 3 months.
- Essential thrombocythemia resistance or intolerance to hydroxurea is defined as essential thrombocythemia patients on HU with platelet count >600 x 10x9/L.
- Dose Expansion Phase (polycythemia vera) and 600 mg/day group (essential thrombocythemia):
Key exclusion criteria (20 listed)
- Less than 18 years of age.
- Participation in any study of an investigational agent (drug, biologic, device) within 30 days prior to initiation of study drug, unless during non-treatment phase. (Prior treatment with another JAK2 inhibitor is allowed.)
- Unwilling to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 3 or 4 at study entry.
- Splenectomy.
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 |
|---|---|---|
| SAR302503Pharmaceutical form:capsule Route of administration: oral | Drug | SAR302503 100 mg, SAR302503 200 mg, SAR302503 400 mg, SAR302503 600 mg |
Primary outcome
Dose Ranging Phase: Proportion of PV patients with absence of phlebotomy and hematocrit below 45% and proportion of ET patients with a platelet count ≤ 400 x 10x9/L for a minimum of 3 months during the first 8 cycles of therapy.
Time frame: 2 years
PV Dose Expansion Phase: Proportion of PV patients with absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit.
Time frame: 2 years
ET Dose Ranging Phase (only 600 mg dose group): Proportion of ET patients with a platelet count ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Day 1 of Cycle 6 visit.
Time frame: 2 years
11 secondary outcomes
Proportion of PV patients with absence of phlebotomy eligibility beginning at Day 1 of Cycle 4 visit through Cycle 8 (for PV dose expansion phase only).
Time frame: 2 years
Proportion of ET patients with platelet count ≤400 x 10x9/L beginning at Day 1 of Cycle 4 visit and continuing through Cycle 8.
Time frame: 2 years
Characterization of clinicohematologic response (CR, PR, and no Response) defined by European LeukemiaNet beginning at Day 1 of Cycle 6 visit through Cycle 8.
Time frame: 2 years
Percent change in spleen volume (per Magnetic Resonance Imaging (MRI)) at the end of Cycles 4 and 8 or end of treatment (EOT) relative to baseline.
Time frame: 2 years
Proportion of patients with a ≥ 35% reduction in spleen volume (per Magnetic Resonance Imaging (MRI)) at the end of Cycles 4 and 8 or end of treatment (EOT) relative to baseline.
Time frame: 2 years
Number of participants who have changes in histological, cytogenetic, and molecular responses in bone marrow.
Time frame: 2 years
Response (defined as either a 2-point improvement in or resolution of a symptom present at baseline) at the end of Cycles 1, 4, and 8 or end of treatment (EOT), as measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF).
Time frame: 2 years
Cumulative Distribution Function of responses between treatment groups at the end of Cycles 1, 4, and 8 or EOT on the MPN-SAF.
Time frame: 2 years
For each MPN-associated symptom present at baseline on the MPN-SAF, proportion of patients with resolution of that symptom at the end of Cycles 1, 4, and 8.
Time frame: 2 years
To measure generic health-related quality of life and utility values using the EQ-5D questionnaire after completion of 8 cycles of therapy.
Time frame: 2 years
Characterization of the safety profile of SAR302503, including the frequency, duration, and severity of adverse events graded using the National Cancer Institute (NCI) - CTCAE version 4.03, clinical laboratory parameters, ECG, and vital signs.
Time frame: 2 years
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 5 Mar 2025.
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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.
Clinical Sciences & Operations study director
Sanofi
35 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAR302503 in people with Hematopoietic Neoplasm, run by Bristol-Myers Squibb at 35 sites in 9 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 9 inclusion and 20 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 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Australia, South Korea, Spain, United Kingdom and 4 more countries. 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?
Dose Ranging Phase: Proportion of PV patients with absence of phlebotomy and hematocrit below 45% and proportion of ET patients with a platelet count ≤ 400 x 10x9/L for a minimum of 3 months during the first 8 cycles of therapy. (time frame: 2 years). The study lists 3 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 5 Mar 2025.