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

Kanisa Pharmaceuticals100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Leukemia, Myeloid

Interventions

ZosuquidarDRUG

DaunorubicinDRUG

CytarabineDRUG

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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