drugset / Trial / NCT05456269
A Study of Bisantrene Combined With Cytarabine or With Decitabine for Adult Subjects With Extramedullary AML and MDS
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a two strata Phase 1b study to assess the safety and efficacy of bisantrene (RC110) in combination with a) cytarabine arabinoside (Ara-C) treatment for patients with relapsed or refractory (R/R) Acute Myeloid Leukemia (AML) with extramedullary disease and able to tolerate intensive chemotherapy; b) in combination with decitabine/cedazuridune (ASTX727) new or relapsed or refractory AML or high risk MDS or CMML with extramedullary disease and unable or not willing to have intensive chemotherapy.
Timeline
- Start
- 2022-07-29
- Primary completion
- 2023-08-31
- Completion
- 2023-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bisantrene | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Bisantrene | Small molecule | 65 mg/m2 | Intravenous |
| Subject | Bisantrene | Small molecule | 85 mg/m2 | Intravenous |
| Subject | Bisantrene | Small molecule | 225 mg/m2 | Intravenous |
| Subject | Bisantrene | Small molecule | 250 mg/m2 | Intravenous |
| Subject | Bisantrene | Small molecule | 275 mg/m2 | Intravenous |
| Background | Cedazuridine | Small molecule | 100 mg | Oral |
| Background | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Background | Decitabine | Small molecule | 35 mg | Oral |