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

Sponsor:	Kanisa Pharmaceuticals
Information provided by:	Kanisa Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00129168

Purpose

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 I Phase II

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, 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:

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

Drug Information available for: Cytarabine hydrochloride Daunorubicin Daunorubicin hydrochloride Zosuquidar Cytarabine

U.S. FDA Resources

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:

Purpose:

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.

Eligibility

Ages Eligible for Study:	55 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	KAN-979-01
Study First Received:	August 9, 2005
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00129168 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kanisa Pharmaceuticals:

Leukemia, Myeloid
Relapse
Chemotherapy
Zosuquidar
Daunorubicin

Cytarabine
Acute
AML
Adult AML
Acute

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Daunorubicin
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid

Antibiotics, Antineoplastic
Leukemia, Myeloid, Acute
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Leukemia
Neoplasms
Therapeutic Uses
Cytarabine

ClinicalTrials.gov processed this record on November 25, 2009