Hematopoietic NeoplasmPhase 2JAKARTA2NCT01523171
Phase II, Open Label, Single Arm Study of SAR302503 In Myelofibrosis Patients Previously Treated With Ruxolitinib
A Phase 2 study testing SAR302503 in people with Hematopoietic Neoplasm, run by Bristol-Myers Squibb at 42 sites in 10 countries.
Trial summary
Primary Objective: To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential… 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
- 97 participants
- Where
- 42 sitesin 10 countries
- Study dates
- 30 Apr 2012to 30 Apr 2014
- 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
- Diagnosis of PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT response criteria
- Subjects who previously received Ruxolitinib treatment for PMF or Post-PV MF or Post-ET MF or PV or ET for at least 14 days (exposure of <14 days is allowed for subjects who discontinued Ruxolitinib due to intolerability or allergy) and discontinued the treatment for at least 14 days prior to the first dose of SAR302503
- MF classified as Intermediate-1 with symptoms, Intermediate-2 or high-risk by Dynamic International Prognostic Scoring System (Passamonti et al., Blood 2010)
- Spleen ≥5 cm below costal margin as measured by palpation
- Male and female subjects ≥18 years of age
- Signed written informed consent
Who cannot join
- Splenectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of >2 before the first dose of SAR302503 at Cycle 1 Day1
- The following laboratory values within 14 days prior to the initiation of SAR302503:
- Absolute Neutrophil Count (ANC) <1.0 x 10exp9/L
- Platelet count <50 x 10exp9/L
- Serum creatinine >1.5 x Upper limit of normal (ULN)
Show all 16Show fewer
- Serum amylase and lipase >1.5 x ULN
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN
- Total bilirubin ≥3.0 x ULN
- Subjects with total bilirubin between 1.5-3.0 x ULN must be excluded if the direct bilirubin fraction is ≥25% of the total
- Subjects with 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])
- Subjects with any other prior malignancies are not eligible, except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which subject has been disease-free for at least 5 years
- Any chemotherapy, immunomodulatory drug therapy (eg, thalidomide, interferon-alpha), Anagrelide, immunosuppressive therapy, corticosteroids >10 mg/day prednisone or equivalent, or growth factor treatment (eg, erythropoietin), or hormones (eg, androgens, danazol) within 14 days prior to initiation of SAR302503; darbepoetin use within 28 days prior to initiation of SAR302503.The only chemotherapy allowed will be hydroxyurea within 1 day prior to initiation of SAR302503
- Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of SAR302503
- 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
42 sites in 10 countries.
42 sites in 10 countries
United States16 sites
Investigational Site Number 840010
Ann Arbor, Michigan, 48109-0759
Investigational Site Number 840005
Atlanta, Georgia, 30322
Investigational Site Number 840017
Baltimore, Maryland, 21201
Investigational Site Number 840013
Baltimore, Maryland, 21229
Investigational Site Number 840024
Charleston, South Carolina, 29406
Investigational Site Number 840014
Chicago, Illinois, 60637
Investigational Site Number 840022
Cleveland, Ohio, 44195
Investigational Site Number 840002
Houston, Texas, 77030
Investigational Site Number 840001
Kansas City, Kansas, 66160-7321
Investigational Site Number 840019
Middletown, Ohio, 45042
Investigational Site Number 840009
New York, New York, 10021
Investigational Site Number 840018
New York, New York, 10032
Investigational Site Number 840007
Phoenix, Arizona, 85054
Investigational Site Number 840015
Salt Lake City, Utah, 84112-5550
Investigational Site Number 840003
San Francisco, California, 94143
Investigational Site Number 840004
San Francisco, California, 94143
France5 sites
Investigational Site Number 250001
Marseille, 13273
Investigational Site Number 250003
Nîmes, 30029
Investigational Site Number 250002
Paris, 75475
Investigational Site Number 250006
Paris, 75571
Investigational Site Number 250004
Toulouse, 31000
Germany5 sites
Investigational Site Number 276003
Frankfurt am Main, 60590
Investigational Site Number 276007
Leipzig, 04103
Investigational Site Number 276006
Magdeburg, 39120
Investigational Site Number 276001
Mannheim, 68167
Investigational Site Number 276005
Ulm, 89081
Italy4 sites
Investigational Site Number 380004
Florence, 50134
Investigational Site Number 380001
Milan, 20122
Investigational Site Number 380002
Roma, 00161
Investigational Site Number 380003
Varese, 21100
Netherlands3 sites
Investigational Site Number 528002
Amsterdam, 1081 HV
Investigational Site Number 528003
Maastricht, 6229 HX
Investigational Site Number 528001
Nijmegen, 6525 GA
Spain3 sites
Investigational Site Number 724001
Barcelona, 08036
Investigational Site Number 724003
Majadahonda, 28222
Investigational Site Number 724002
Salamanca, 37007
Austria2 sites
Investigational Site Number 040002
Salzburg, 5020
Investigational Site Number 040001
Vienna, 1090
Belgium2 sites
Investigational Site Number 056002
Antwerp, 2060
Investigational Site Number 056003
Leuven, 3000
United Kingdom1 site
Investigational Site Number 826001
London, SE1 9RT
About this study
Official title: A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Primary Objective:
- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles;
Read more
Secondary Objectives:
- To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
- To evaluate the durability of splenic response
- To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
- To evaluate the splenic response to SAR302503 at the end of Cycle 3
- To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
- To evaluate the safety and tolerability of SAR302503 in this population
- To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted
Read the detailed description
The expected duration of the treatment in this study is approximately 8 months, based on a maximum 28-day screening period, followed by a 6-month (6-cycle) treatment period, and an EOT visit for subjects who will not continue the treatment after completing the 6 cycles of SAR302503, or discontinue the treatment early for any reasons as well as a follow-up visit which should occur 30 days after the last administration of SAR302503. Patients who continue to benefit clinically will be allowed to remain on study medication beyond the 6-month treatment period until the occurrence of disease progression or unacceptable toxicity.
- 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 400 mg | Experimental | once daily in consecutive 28-day cycles, flexible dosing regimen (the starting dose is 400mg/day), orally, empty stomach, approximately same time each day Receives: Drug: SAR302503 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate: Percentage of Participants With >=35% Reduction From Baseline in Spleen Volume at End of Cycle 6
Spleen volume was measured by central imaging MRI (CT scan in participants with contraindications for MRI). Analysis was performed on Per Protocol (PP) population defined as all treated participants with a baseline and at least one post-baseline MRI/CT scan of spleen volume, and had no important protocol deviations that could impact on efficacy outcome. Last observation carried forward (LOCF) method was used to impute the missing data.
Measured: Baseline, End of Cycle 6
Secondary outcomes (5)
Symptom Response Rate: Percentage of Participants With >=50% Reduction From Baseline in the Total Symptom Score Using MFSAF at End of Cycle 6
The key MF-associated symptoms were assessed using the modified Myelofibrosis Symptom Assessment Form (MFSAF) Diary: night sweats, pruritus, abdominal discomfort, early satiety, pain under ribs on left side, and bone or muscle pain. These were measured on a scale from 0 (absent) to 10 (worst imaginable). Then Total symptom score (range 0 to 60) was defined as the sum of the scores for each of the 6 symptoms of MFSAF. Higher score indicated greater severity of symptoms. Analysis was performed on MFSAF analysis population defined as all treated participants with baseline and at least 1 post-baseline evaluable assessment of total symptom score.
Measured: Baseline, End of Cycle 6
Percentage of Participants With a ≥50% Reduction From Baseline in Length of Spleen by Palpation at End of Cycle 6
Percentage of Participants with a ≥50% Reduction From Baseline in Length of Spleen by Palpation at End of Cycle 6.
Measured: Baseline, End of Cycle 6
Response Rate: Percentage of Participants With ≥35% Reduction From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3
Percentage of Participants With ≥35% Reduction From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3. Analysis was performed on PP population.
Measured: Baseline, End of Cycle 3
Percent Change From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3 and Cycle 6.
Percent Change From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3 and Cycle 6. Analysis was performed on PP population.
Measured: Baseline, End of Cycle 3, 6
Plasma Concentration of Fedratinib
Analysis was performed on pharmacokinetic population defined as all participants who received at least 1 (even partial) cycle of study treatment and had evaluable drug concentration data.
Measured: Pre-dose (Hour 0), 0.5, 2.5 hours post-dose on Day 1 of Cycle 1, 2, pre-dose (Hour 0) on Day 1 of Cycle 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study start30 Apr 2012
- Primary completion30 Apr 2014
- Study completion30 Apr 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 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
- NCT01523171
- Sponsor's protocol ID
- ARD12181
- Other IDs
- 2011-005226-21, U1111-1124-0967
- Acronym
- JAKARTA2
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2012
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Harrison CN, Schaap N, Vannucchi AM, Kiladjian JJ, Tiu RV, Zachee P, Jourdan E, Winton E, Silver RT, Schouten HC, Passamonti F, Zweegman S, Talpaz M, Lager J, Shun Z, Mesa RA. Janus kinase-2 inhibitor fedratinib in patients with myelofibrosis previously treated with ruxolitinib (JAKARTA-2): a single-arm, open-label, non-randomised, phase 2, multicentre study. Lancet Haematol. 2017 Jul;4(7):e317-e324. doi: 10.1016/S2352-3026(17)30088-1. Epub 2017 Jun 8.
PubMed 28602585
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open Label, Single Arm Study of SAR302503 in Subjects Previously Treated With Ruxolitinib and With a Current Diagnosis of Intermediate or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
- ClinicalTrials.gov ID
- NCT01523171
- Acronym / sponsor ID
- JAKARTA2 / ARD12181
- Conditions
- Hematopoietic Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2012 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To evaluate the efficacy of once daily dose of SAR302503 in subjects previously treated with ruxolitinib and with a current diagnosis of intermediate-1 with symptoms, Intermediate-2 or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (Post-PV MF), or post-essential thrombocythemia myelofibrosis (Post-ET MF) based on the reduction of spleen volume at the end of 6 treatment cycles;
Secondary Objectives:
- To evaluate the effect of SAR302503 on Myelofibrosis (MF) associated symptoms as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary
- To evaluate the durability of splenic response
- To evaluate the splenic response to SAR302503 by palpation at the end of Cycle 6
- To evaluate the splenic response to SAR302503 at the end of Cycle 3
- To evaluate the effect of SAR302503 on the Janus kinase 2 (JAK2) V617F allele burden
- To evaluate the safety and tolerability of SAR302503 in this population
- To evaluate plasma concentrations of SAR302503 for population PK analysis, if warranted
Detailed description
The expected duration of the treatment in this study is approximately 8 months, based on a maximum 28-day screening period, followed by a 6-month (6-cycle) treatment period, and an EOT visit for subjects who will not continue the treatment after completing the 6 cycles of SAR302503, or discontinue the treatment early for any reasons as well as a follow-up visit which should occur 30 days after the last administration of SAR302503. Patients who continue to benefit clinically will be allowed to remain on study medication beyond the 6-month treatment period until the occurrence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SAR302503 400 mg | Experimental | Drug: SAR302503once daily in consecutive 28-day cycles, flexible dosing regimen (the starting dose is 400mg/day), orally, empty stomach, approximately same time each day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of PMF or Post-PV MF or Post-ET MF, according to the 2008 World Health Organization and IWG-MRT response criteria
- Subjects who previously received Ruxolitinib treatment for PMF or Post-PV MF or Post-ET MF or PV or ET for at least 14 days (exposure of <14 days is allowed for subjects who discontinued Ruxolitinib due to intolerability or allergy) and discontinued the treatment for at least 14 days prior to the first dose of SAR302503
- MF classified as Intermediate-1 with symptoms, Intermediate-2 or high-risk by Dynamic International Prognostic Scoring System (Passamonti et al., Blood 2010)
- Spleen ≥5 cm below costal margin as measured by palpation
- Male and female subjects ≥18 years of age
Key exclusion criteria (16 listed)
- Splenectomy
- Eastern Cooperative Oncology Group (ECOG) performance status of >2 before the first dose of SAR302503 at Cycle 1 Day1
- The following laboratory values within 14 days prior to the initiation of SAR302503:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 x ULN
- Total bilirubin ≥3.0 x ULN
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 400 mg |
Primary outcome
Response Rate: Percentage of Participants With >=35% Reduction From Baseline in Spleen Volume at End of Cycle 6
Time frame: Baseline, End of Cycle 6
Spleen volume was measured by central imaging MRI (CT scan in participants with contraindications for MRI). Analysis was performed on Per Protocol (PP) population defined as all treated participants with a baseline and at least one post-baseline MRI/CT scan of spleen volume, and had no important protocol deviations that could impact on efficacy outcome. Last observation carried forward (LOCF) method was used to impute the missing data.
5 secondary outcomes
Symptom Response Rate: Percentage of Participants With >=50% Reduction From Baseline in the Total Symptom Score Using MFSAF at End of Cycle 6
Time frame: Baseline, End of Cycle 6
Percentage of Participants With a ≥50% Reduction From Baseline in Length of Spleen by Palpation at End of Cycle 6
Time frame: Baseline, End of Cycle 6
Response Rate: Percentage of Participants With ≥35% Reduction From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3
Time frame: Baseline, End of Cycle 3
Percent Change From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3 and Cycle 6.
Time frame: Baseline, End of Cycle 3, 6
Plasma Concentration of Fedratinib
Time frame: Pre-dose (Hour 0), 0.5, 2.5 hours post-dose on Day 1 of Cycle 1, 2, pre-dose (Hour 0) on Day 1 of Cycle 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28602585Harrison CN, Schaap N, Vannucchi AM, Kiladjian JJ, Tiu RV, Zachee P, Jourdan E, Winton E, Silver RT, Schouten HC, Passamonti F, Zweegman S, Talpaz M, Lager J, Shun Z, Mesa RA. Janus kinase-2 inhibitor fedratinib in patients with myelofibrosis previously treated with ruxolitinib (JAKARTA-2): a single-arm, open-label, non-randomised, phase 2, multicentre study. Lancet Haematol. 2017 Jul;4(7):e317-e324. doi: 10.1016/S2352-3026(17)30088-1. Epub 2017 Jun 8.
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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
42 sites in 10 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 42 sites in 10 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 6 inclusion and 16 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, France, Germany, Italy, Netherlands and 5 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?
Yes. Results are posted in the registry (first posted 16 Jul 2026). 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?
Response Rate: Percentage of Participants With >=35% Reduction From Baseline in Spleen Volume at End of Cycle 6 (time frame: Baseline, End of Cycle 6). 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 NCT01523171, 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 16 Jul 2026.