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

Kanisa Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Leukemia, Myeloid

Treatments: Drug: Daunorubicin; Drug: Zosuquidar; Drug: Cytarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00129168

KAN-979-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)