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

This study has been completed.
Sponsor:
Information provided by:
Kanisa Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00129168
First received: August 9, 2005
Last updated: March 28, 2008
Last verified: March 2008
History of Changes
  Purpose

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 Intervention Phase
Leukemia, Myeloid
 Drug: Zosuquidar
Drug: Daunorubicin
Drug: Cytarabine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kanisa Pharmaceuticals:

Estimated Enrollment: 100
Study Start Date: August 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00129168     History of Changes
Other Study ID Numbers: KAN-979-01
Study First Received: August 9, 2005
Last Updated: March 28, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Kanisa Pharmaceuticals:
Leukemia, Myeloid
Relapse
Chemotherapy
Zosuquidar
Daunorubicin
 Cytarabine
Acute
AML
Adult AML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on May 19, 2013