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

This study has been completed.

Sponsor:

Information provided by:

Kanisa Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00233909

First received: October 4, 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 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 Endpoint Classification: Safety/Efficacy Study 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:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Genetic and Rare Diseases Information Center resources: Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Acute Non Lymphoblastic Leukemia Leukemia, Myeloid

U.S. FDA Resources

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

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


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

Keywords provided by Kanisa Pharmaceuticals:


Leukemia, Myeloid Relapse Chemotherapy Zosuquidar gemtuzumab ozogamicin (GO)

Additional relevant MeSH terms:


Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type	Gemtuzumab Antineoplastic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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