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drugset / Trial / NCT00583102

Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AML

NCT00583102 ↗

Phase 1/2 Terminated 23 enrolled University of Iowa
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety and effectiveness of combining a drug known as Lovastatin to the chemotherapy drug cytarabine. Lovastatin is currently used to lower blood cholesterol levels and lab data suggests that it increases the anti-leukemia activity of cytarabine. This research is being done because high doses of cytarabine induce remissions in only about 25% of patients with acute myeloid leukemia.

Timeline

Start
2001-06
Primary completion
2013-02
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 3000 mg/m2 Intravenous
Subject Lovastatin Small molecule 0.5 mg/kg Oral
Subject Lovastatin Small molecule 1 mg/kg Oral
Subject Lovastatin Small molecule 2 mg/kg Oral
Subject Lovastatin Small molecule 4 mg/kg Oral
Subject Lovastatin Small molecule 8 mg/kg Oral
Subject Lovastatin Small molecule 12 mg/kg Oral
Subject Lovastatin Small molecule 18 mg/kg Oral
Subject Lovastatin Small molecule 24 mg/kg Oral

Indications

acute myeloid leukemia