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

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kanisa Pharmaceuticals
• Treatments: Cytarabine; Daunorubicin

Criteria

Inclusion Criteria:

• Newly diagnosed acute myeloid leukemia

• Ages 55-75 years

Exclusion Criteria:

• Acute promyelocytic leukemia (FAB M3)

• Patients must not have received prior chemotherapy for AML.

• Prior exposure to anthracycline

• Use of any investigational agent within 4 weeks prior to enrollment into the study

For Phase II:

• Patients must be P-glycoprotein positive