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Clinical Trials/NCT00129168
NCT00129168CompletedPhase 1

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

Kanisa Pharmaceuticals0 sites100 target enrollmentStarted: August 1, 2005Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
100

Study Overview

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.

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
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
55 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Investigators

Sponsor
Kanisa Pharmaceuticals
Sponsor Class
Industry

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