Myelodysplastic Syndrome
Conditions
Brief summary
1. Percentage of participants with RBC-TI (rolling 12 weeks), 2. Selected safety endpoints: Grade >= 3 AE, AEs leading to treatment discontinuation and/or dose modifications, 3. Pharmacokinetic parameters of momelotinib and M21 (e.g., Cmax, AUC), as data permit
Detailed description
1. Percentage of participants with ≥12 weeks of RBC-TI by the end of Week 24, 2. Incidence and severity of AEs and SAEs, and AEs leading to treatment discontinuation or dose modifications by the end of Week 24 and longer term, 3. Clinically important changes in laboratory parameters and vital signs by the end of Week 24 and longer term, 4. Plasma concentration of momelotinib and M21
Interventions
None listed
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with RBC-TI (rolling 12 weeks), 2. Selected safety endpoints: Grade >= 3 AE, AEs leading to treatment discontinuation and/or dose modifications, 3. Pharmacokinetic parameters of momelotinib and M21 (e.g., Cmax, AUC), as data permit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with ≥12 weeks of RBC-TI by the end of Week 24, 2. Incidence and severity of AEs and SAEs, and AEs leading to treatment discontinuation or dose modifications by the end of Week 24 and longer term, 3. Clinically important changes in laboratory parameters and vital signs by the end of Week 24 and longer term, 4. Plasma concentration of momelotinib and M21 | — |
Countries
France, Germany, Italy, Poland, Spain
Outcome results
None listed