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

This study has been completed.

First Received: October 4, 2005 Last Updated: March 28, 2008 History of Changes

Sponsored by:	Kanisa Pharmaceuticals
Information provided by:	Kanisa Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00233909

Purpose

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 I Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Zosuquidar Gemtuzumab ozogamicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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

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:

Purpose:

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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	KAN-979-02
Study First Received:	October 4, 2005
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00233909 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kanisa Pharmaceuticals:

Leukemia, Myeloid
Relapse
Chemotherapy
Zosuquidar
gemtuzumab ozogamicin (GO)

Study placed in the following topic categories:

Antibodies, Monoclonal
Leukemia
Antibodies
Acute Myelocytic Leukemia
Immunologic Factors

Leukemia, Myeloid
Gemtuzumab
Leukemia, Myeloid, Acute
Immunoglobulins

Additional relevant MeSH terms:

Antibodies, Monoclonal
Leukemia
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Leukemia, Myeloid
Gemtuzumab
Leukemia, Myeloid, Acute
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009