Phase I Study of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

This study has been withdrawn prior to recruitment.

( Insufficient Enrollment )

First Received: May 9, 2006 Last Updated: July 24, 2008 History of Changes

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00324077

Purpose

The purpose of this study is to find out whether adding a new drug, dasatinib, to imatinib is safe, and whether the combination of the two drugs will help decrease the number of cells that contain the Philadelphia chromosome.

Condition	Intervention	Phase
Myeloid Leukemia, Chronic, Chronic-Phase	Drug: Dasatinib in combination with imatinib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Dose Escalation Study of the Combination of Dasatinib (BMS-354825) and Imatinib in Subjects With Chronic Myeloid Leukemia in Chronic Phase

Resource links provided by NLM:

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

Drug Information available for: Imatinib Imatinib mesylate Dasatinib

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To determine the maximum tolerated dose (MTD) and recommended dose of dasatinib when combined with imatinib in chronic phase CML patients.

Secondary Outcome Measures:

assess safety and tolerability of dasatinib and imatinib administered in combination throughout study
identify dose limiting toxicities
characterize plasma pharmacokinetics of dasatinib and imatinib in month 1
measure major molecular response rate
measure the major cytogenetic response rate
characterize mutations in the BCR-ABL gene
evaluate progressive free survival and overall survival

Estimated Enrollment:	76
Study Start Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

males and females, 18 or older
chronic phase Ph+ or BCR-ABL positive CML
current complete hematologic response to imatinib
lack of major molecular response
on imatinib for at least one year
on the same imatinib dose for at least 6 months
adequate hepatic and renal function

Exclusion Criteria:

History of accelerated or blast phase CML
Serious uncontrolled medical disorder or active infection
Significant cardiovascular disease or bleeding disorder
Concurrent use of medications at risk of causing Torsades de Pointe

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324077

Locations

United States, California
Local Institution
Los Angeles, California, United States
Local Institution
San Francisco, California, United States
United States, New York
Local Institution
New York, New York, United States

Sponsors and Collaborators

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CA180-011
Study First Received:	May 9, 2006
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00324077 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Chronic phase chronic myelogenous leukemia (CML)

Study placed in the following topic categories:

Imatinib
Leukemia
Hematologic Diseases
Dasatinib
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Chronic Myelogenous Leukemia
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases
Protein Kinase Inhibitors

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Protein Kinase Inhibitors

Pharmacologic Actions
Imatinib
Leukemia
Neoplasms
Therapeutic Uses
Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 01, 2009