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

This study has been completed.
Information provided by:
Kanisa Pharmaceuticals Identifier:
First received: October 4, 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 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 Intervention Phase
Leukemia, Myeloid
Drug: Zosuquidar
Drug: gemtuzumab ozogamicin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Kanisa Pharmaceuticals:

Estimated Enrollment: 55
Study Start Date: October 2005
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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 Identifier: NCT00233909     History of Changes
Other Study ID Numbers: KAN-979-02
Study First Received: October 4, 2005
Last Updated: March 28, 2008

Keywords provided by Kanisa Pharmaceuticals:
Leukemia, Myeloid
gemtuzumab ozogamicin (GO)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents processed this record on April 28, 2017