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A Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233909
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : April 1, 2008
Information provided by:
Kanisa Pharmaceuticals

Brief Summary:
Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help Gemtuzumab Ozogamicin (GO) kill more cancer cells by making cancer cells more sensitive to the drug. It is not known whether Gemtuzumab Ozogamicin (GO) is more effective with or without zosuquidar in treating acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid Drug: Zosuquidar Drug: gemtuzumab ozogamicin Phase 1 Phase 2

Detailed Description:


Phase I: Determine the optimal dose and schedule of GO and zosuquidar when used in combination.

Phase II: Determine the complete remission rate (CR+CRp)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I/II Trial of Gemtuzumab Ozogamicin (GO) in Combination With Zosuquidar in Patients With CD33 Positive Acute Myeloid Leukemia
Study Start Date : October 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Morphologic evidence of acute myeloid leukemia in first relapse.
  2. Phase I: 18 years or older, Phase II: 50 years or older

Exclusion Criteria:

  1. Prior treatment with zosuquidar
  2. Any investigational agent within 1 month of enrollment and lack of recovery from toxicities secondary to those agents
  3. History of stem cell transplant

Layout table for additonal information Identifier: NCT00233909     History of Changes
Other Study ID Numbers: KAN-979-02
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008
Keywords provided by Kanisa Pharmaceuticals:
Leukemia, Myeloid
gemtuzumab ozogamicin (GO)
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents