NCT00512083

Phase II Study of AS1411 Combined With Cytarabine to Treat Acute Myeloid Leukemia

An Open Label Randomized Controlled Dose Escalating Phase II Study of AS1411 Combined With Cytarabine in the Treatment of Patients With Primary Refractory or Relapsed Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Antisoma Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this study is to assess the efficacy and safety of AS1411, over a range of doses, when combined with cytarabine, in the treatment of patients with primary refractory or relapsed acute myeloid leukemia (AML).

Conditions

• Leukemia, Myeloid

Interventions

Type	Name	Description
DRUG	AS1411	AS1411 IV administration continuously over 7 days. Dose either 10mg/kg/day or 40 mg/kg/day.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-04-01
• First posted: 2007-08-07
• Last updated: 2009-09-25

Locations

10 sites across 2 countries: United States, New Zealand