NCT00129168

Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)

An Open-Label, Phase I/II, Multicenter Dose Escalation Study of Zosuquidar, Daunorubicin, and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kanisa Pharmaceuticals · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.

Detailed description

Purpose: Phase I: To Evaluate the safety of different doses of zosuquidar. Phase II: This study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.

Conditions

• Leukemia, Myeloid

Interventions

Type	Name	Description
DRUG	Zosuquidar
DRUG	Daunorubicin
DRUG	Cytarabine

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2005-08-11
• Last updated: 2008-04-01