drugset / Trial / NCT00780143
Clinical Study of Plitidepsin (Aplidin®) in Combination With Cytarabine in Patients With Relapsed/Refractory Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase I/II study to determine the safety, tolerability and to identify the MTD and DLT of Plitidepsin in combination with a fixed dose of Cytarabine in patients with relapsed/refractory leukemia and to determine the response rate of the combination of Plitidepsin with Cytarabine in patients with relapsed/refractory AML treated at the MTD.
Timeline
- Start
- 2007-11
- Primary completion
- 2009-06
- Completion
- 2009-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 1000 mg/m2 | — |
| Subject | Plitidepsin | Peptide | 0.54 mg/m2 | — |