Extension study of WT4869 for MDS
Phase 1
Completed
- Conditions
- Myelodysplastic syndromes
- Registration Number
- JPRN-jRCT2080222621
- Lead Sponsor
- Sumitomo Dainippon Pharma Co., Ltd.
- Brief Summary
The aim of this study was to evaluate safety and efficacy of long-term administration of WT4869 in MDS patients.The dose was allowed to be increased by one step to 600 mcg per body for each dose after the second dose in this study. The dose was increased in 4 patients.The dose was increased to 600 mcg per body in 3 patients, which was the highest dose, but there were no major safety concerns. Hematologic response occurred in 3 of 6 patients. Two of these patients responded in the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
Patients who completed Phase I/II study
Exclusion Criteria
Patients with concomitant infections of Grade 3 or greater
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>To assess the safety and efficacy of long-term treatment with WT4869<br>Safety: adverse events, clinical laboratory test, vital sign, body weight, 12-led ECG<br>Efficacy: hematologic improvement/treatment or cytogenetic response, time to AML, overall survival
- Secondary Outcome Measures
Name Time Method efficacy<br>Hematologic response and hematologic improvement (erythroid, platelet, or neutrophil)