A Phase 2 interventional study of SAR302503 in Hematopoietic Neoplasm, sponsored by Bristol-Myers Squibb. Terminated at 42 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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:
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.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 97 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
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Exclusion criteria:
The following laboratory values within 14 days prior to the initiation of SAR302503:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
once daily in consecutive 28-day cycles, flexible dosing regimen (the starting dose is 400mg/day), orally, empty stomach, approximately same time each day
Drug: SAR302503
Pharmaceutical form:capsule Route of administration: oral
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.
Time frame: Baseline, End of Cycle 6
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.
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
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
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.
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.
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.
Time frame: 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.
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
The study was conducted at 36 sites in 10 countries. A total of 97 participants were enrolled between 30 April 2012 and 02 August 2013.
| Milestone | Fedratinib |
|---|---|
| Started | 97 |
| Completed | 0 |
| Not completed | 97 |
| Withdrew: Adverse event | 18 |
| Withdrew: Study terminated by sponsor | 63 |
| Withdrew: Allogenic stem cell transplant | 1 |
| Withdrew: Dp-abdominal pain and progressive leucocytosis | 1 |
| Withdrew: Consent withdrawn by participant | 8 |
| Withdrew: Disease progression (dp) | 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.
| percentage of participants | Fedratinib |
|---|---|
| Response Rate: Percentage of Participants With >=35% Reduction From Baseline in Spleen Volume at End of Cycle 6 | 55.4 ± 44.1 |
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.
| percentage of participants | Fedratinib |
|---|---|
| Symptom Response Rate: Percentage of Participants With >=50% Reduction From Baseline in the Total Symptom Score Using MFSAF at End of Cycle 6 | 25.6 ± 16.9 |
Percentage of Participants with a ≥50% Reduction From Baseline in Length of Spleen by Palpation at End of Cycle 6.
| percentage of participants | Fedratinib |
|---|---|
| Percentage of Participants With a ≥50% Reduction From Baseline in Length of Spleen by Palpation at End of Cycle 6 | 30.9 |
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.
| percentage of participants | Fedratinib |
|---|---|
| Response Rate: Percentage of Participants With ≥35% Reduction From Baseline in Spleen Volume Measured by MRI or CT Scan at End of Cycle 3 | 47 |
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.
| percent change from baseline | Fedratinib |
|---|---|
| End of Cycle 3 (n=20) | -24.3 (-60.6 to 22) |
| End of Cycle 6 (n=83) | -34.01 (-72.7 to 114.8) |
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.
| ng/mL | Fedratinib |
|---|---|
| Cycle 1 Predose (0 hours) (n=94) | 1 ± 0 |
| Cycle 1 Day 1 (0.5 to 2 hours) (n=93) | 924.8 ± 605.4 |
| Cycle 1 Day 1 (2.5 to 4 hours) (n=93) | 1302.8 ± 708.6 |
| Cycle 2 Day 1 Predose (0 hours) (n=85) | 1150.1 ± 652.5 |
| Cycle 2 Day 1 (0.5 to 2 hours) (n=85) | 1873.4 ± 1081 |
| Cycle 2 Day 1 (2.5 to 4 hours) (n=87) | 2143 ± 906.6 |
| Cycle 4 Day 1 Predose (0 hours) (n=69) | 1258.7 ± 594.9 |
Collected over Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 79) regardless of seriousness or relationship to investigational product. Analysis was performed on safety population.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fedratinib | 7/97 (7.2%) | 33/97 (34%) | 95/97 (97.9%) |
| Event | Fedratinib |
|---|---|
| PneumoniaInfections and infestations | 4/97 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 3/97 |
| FallInjury, poisoning and procedural complications | 2/97 |
| DehydrationMetabolism and nutrition disorders | 2/97 |
| Acute Myeloid LeukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/97 |
| AnaemiaBlood and lymphatic system disorders | 1/97 |
| SplenomegalyBlood and lymphatic system disorders | 1/97 |
| PancytopeniaBlood and lymphatic system disorders | 1/97 |
| Acute Coronary SyndromeCardiac disorders | 1/97 |
| Thrombotic Thrombocytopenic PurpuraBlood and lymphatic system disorders | 1/97 |
| Event | Fedratinib |
|---|---|
| DiarrhoeaGastrointestinal disorders | 59/97 |
| NauseaGastrointestinal disorders | 54/97 |
| AnaemiaBlood and lymphatic system disorders | 47/97 |
| VomitingGastrointestinal disorders | 40/97 |
| ThrombocytopeniaBlood and lymphatic system disorders | 26/97 |
| ConstipationGastrointestinal disorders | 20/97 |
| PruritusSkin and subcutaneous tissue disorders | 16/97 |
| FatigueGeneral disorders | 15/97 |
| HeadacheNervous system disorders | 13/97 |
| CoughRespiratory, thoracic and mediastinal disorders | 13/97 |
| Age, Continuous(years) | Fedratinib |
|---|---|
| Mean | 66.5 ± 8.1 |
| Sex: Female, Male(Participants) | Fedratinib |
|---|---|
| Female | 44 |
| Male | 53 |
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb