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

Sponsor

Kanisa Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00129168

Collaborator

(none)

100

Enrollment

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Myeloid	Drug: Zosuquidar Drug: Daunorubicin Drug: Cytarabine	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Mar 1, 2008

Actual Study Completion Date :

Mar 1, 2008

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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