drugset / Trial / NCT03486353
A Study of FF-10501-01 in Combination with Azacitidine in Patients with Myelodysplastic Syndrome
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine the response rate according to the International Working Group Response criteria for the combination of FF-10501-01 and azacitidine in patients previously untreated with hypomethylating agents, with Int2/High risk MDS according to the IPSS, and Intermediate/High/Very-High risk MDS according to the IPSS-R, or who are otherwise candidates for treatment with azacitidine.
Timeline
- Start
- 2019-10-01
- Primary completion
- 2019-10-01
- Completion
- 2019-10-01
Outcome
Outcome not reported
Stopped: “Program terminated”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | FF-10501-01 | Unknown | 400 mg/m2 | — |