Status:

COMPLETED

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

Lead Sponsor:

Kanisa Pharmaceuticals

Conditions:

Leukemia, Myeloid

Eligibility:

All Genders

55-75 years

Phase:

PHASE1

PHASE2

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...

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 cyt...

Eligibility Criteria

Inclusion

  • Newly diagnosed acute myeloid leukemia
  • Ages 55-75 years

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2008

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT00129168

Start Date

August 1 2005

End Date

March 1 2008

Last Update

April 1 2008

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