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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Treatment Completed 55 to 75 Pharmaceutical / Industry KAN-979-01
NCT00129168

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Kanisa Pharmaceuticals

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00129168
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.