drugset / Trial / NCT00505700
VELCADE in Combination With Idarubicin and Cytosine Arabinoside in Patients With Acute Myelogenous Leukemia
Phase 1
Completed
36 enrolled
Massachusetts General Hospital
Millennium Pharmaceuticals, Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to establish the maximally tolerated dose of VELCADE that can be administered with idarubicin and cytarabine in patients with AML. The secondary objectives of this study are assessment of efficacy, safety, and pharmacokinetics of Velcade when combined with Cytarabine and idarubicin. Various molecular markers associated with response to Velcade, cytarabine, and idarubicin will be explored by utilizing microarray analyses. The study endpoints are maximum tolerated dose and response to treatment.
Timeline
- Start
- 2003-07
- Primary completion
- 2005-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | — | — |
| Background | Cytarabine | Small molecule | — | — |
| Background | Idarubicin | Small molecule | — | — |