Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Kanisa Pharmaceuticals Identifier:
First received: August 9, 2005
Last updated: March 28, 2008
Last verified: March 2008

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:

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:


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.


Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided 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
Adult AML

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on November 24, 2014