Clinical trial · Interventional
SB1518 for Patients With Myelodysplastic Syndrome (MDS)
Phase II Study of SB1518 for Patients With Myelodysplastic Syndrome (MDS)
NCT01436084CI-TRIAL-00023006terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Colloborating sponsor decision.
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if SB1518 can help to control myelodysplastic syndrome. The safety of the drug will also be studied. SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain leukemias, myelofibrosis, and lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SB1518 | Drug | Pacritinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SB1518
- description
- 400 mg orally a day for 28 day cycle.
- interventionNames
- Drug: SB1518
Primary outcomes (1)
- measure
- Number of Participants With Overall Response
- timeFrame
- 28 days to one year
- description
- Overall response based on hematologic improvement defined by International Working Group (IWG) response criteria in myelodysplasia. Complete remission (CR): Bone marrow of 5% myeloblasts with normal maturation of all cell lines, noted persistent dysplasia; Partial Remission: CR criteria if abnormal before treatment except Bone marrow blasts decreased by 50% over pretreatment but still \> 5%; Marrow CR: Bone marrow 5% myeloblasts and decrease by 50% over pretreatment. Bone marrow aspirate pre-therapy (Day 0) and on Day 28 of first cycle then every 3 cycles. Responses must last at least 4 weeks.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with MDS by the IPSS classification including low, int-1, int-2, and high risk are eligible. Patients should have received at least one line of prior therapy including growth factors, lenalidomide, or hypomethylating agents. 2. Signed informed consent. 3. Age \>/= 18 years old. 4. Patients must have the following non-hematologic values: Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) \</= 2.5 x Upper Limit of Normal (ULN) if both are available or \</= 5.0 x ULN if hepatic involvement is present as determined by the investigator; Serum bilirubin \</=2 x ULN; Serum creatinine \</= 2 x ULN or 24-hour creatinine clearance \>/= 50 ml/min 5. Patients, if sexually active, must agree to use appropriate forms birth control. Exclusion Criteria: 1. Uncontrolled intercurrent illness, including but not limited to ongoing active infection or psychiatric illness or social situations that the treating physician judges would limit compliance with study requirements. Patients receiving antibiotics for infections that are under control may be included in the study. 2. History of myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within 6 months prior to study enrollment; 3. New York Heart Association Class III or IV congestive heart failure; 4. Ongoing cardiac dysrhythmias of Grade \>/= 2, atrial fibrillation of any grade, QTc prolongation \> 470 ms or other factors that increase the risk of QT prolongation (e.g., heart failure; hypokalemia, defined as serum potassium \< 3.0 mEq/L; family history of long QT interval syndrome); 5. Required use of a concomitant medication known to prolong the QT interval significantly. 6. Known HIV seropositivity; 7. Known active hepatitis A, B, or C; 8. Women who are pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.