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Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
Link to the ClinicalTrials.gov recordInformation obtained from ClinicalTrials.gov on February 23, 2012
Title of trial/grant titleChronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
Current status of trialActive, not recruiting
Sponsors and collaboratorsBristol-Myers Squibb
Information provided byBristol-Myers Squibb
ClinicalTrials.gov identifierNCT00123474
PurposeThis is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia
chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant
to imatinib mesylate (Gleevec).
Condition(s)Myeloid Leukemia, Chronic, Chronic-Phase
Intervention(s)Drug: dasatinib
Drug: dasatinib
Drug: dasatinib
Drug: dasatinib
PhasePhase III
Study type and designAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Official titleA Randomized Two-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)
Primary outcomeTo compare the efficacy of BMS-354825 as defined by MCyR when administered QD relative to BMS-354825 administered BID in the treatment of CP CML imatinib-resistant subjects throughout the study No
Secondary outcomeProgression free and overall survival throughout the study No
Comparison of Major Cytogenetic Response rate between two dose levels throughout the study No
Study startJuly 2005
Minimum age18 Years
Maximum age90 Years
GenderBoth
Eligibility criteriaInclusion Criteria:

- Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase
chronic myeloid leukemia whose disease has primary or acquired hematologic resistance
to imatinib mesylate or who are intolerant of imatinib mesylate.

- Men and women, 18 years or older

- Adequate hepatic function

- Adequate renal function

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for a period of at least 1
month before and at least 3 months after the study in such a manner that the risk of
pregnancy is minimized.

Exclusion Criteria:

- Women who are pregnant or breastfeeding

- Subjects who are eligible and willing to undergo transplantation during the screening
period

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy

- Uncontrolled or significant cardiovascular disease

- Medications that increase bleeding risk

- Medications that change heart rhythms

- Dementia or altered mental status that would prohibit the understanding or rendering
of informed consent

- History of significant bleeding disorder unrelated to CML

- Concurrent incurable malignancy other than CML

- Evidence of organ dysfunction or digestive dysfunction that would prevent
administration of study therapy

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious disease) illness must
not be enrolled into this study
Study chairs or principal investigatorsBristol-Myers Squibb, Study Director, Bristol-Myers Squibb
LocationsAlabama, United States

University Of Alabama-Birmingham
Birmingham
Alabama
35294

California, United States

Central Hematology Oncology Medical Group Inc.
Alhambra
California
91801

California, United States

Pacific Cancer Medical Center Inc
Anaheim
California
92801

California, United States

Loma Linda University Cancer Center
Loma Linda
California
92354

California, United States

Pacific Shores Medical Group
Long Beach
California
90813

California, United States

Paquette, Ronald
Los Angeles
California
90095

California, United States

Ventura County Hematology-Oncology Specialists
Oxnard
California
93030

California, United States

Kaiser Permanente Medical Center
Vallejo
California
94589

District of Columbia, United States

Georgetown University Medical Center
Washington
District of Columbia
20007

District of Columbia, United States

Washington Cancer Institute At Washington Hospital Center
Washington
District of Columbia
20010

Florida, United States

University Of Florida
Gainesville
Florida
32610

Florida, United States

University Of Miami
Miami
Florida
33136

Florida, United States

Md Anderson Cancer Center Orlando
Orlando
Florida
32806

Georgia, United States

Georgia Cancer Specialists
Atlanta
Georgia
30341

Georgia, United States

Emory University School Of Medicine
Atlanta
Georgia
30322

Georgia, United States

Suburban Hematology-Oncology Associates, Pc
Lawrenceville
Georgia
30046

Illinois, United States

University Of Chicago
Chicago
Illinois
60637

Illinois, United States

Northwestern University
Chicago
Illinois
60611

Illinois, United States

Illinois Cancer Care
Peoria
Illinois
61615

Indiana, United States

Indiana University Cancer Center
Indianapolis
Indiana
46202

Kansas, United States

University Of Kansas Medical Center
Westwood
Kansas
66205

Kentucky, United States

University Of Kentucky
Lexington
Kentucky
40536

Maryland, United States

University Of Maryland
Baltimore
Maryland
21201

Massachusetts, United States

Dana-Farber Cancer Institute
Boston
Massachusetts
02115

Michigan, United States

Wayne State University
Detroit
Michigan
48201

Missouri, United States

Washington University School Of Medicine
St. Louis
Missouri
63110

Nebraska, United States

Devetten, Marcel
Omaha
Nebraska
68198

Nebraska, United States

Nebraska Methodist Hospital
Omaha
Nebraska
68114

Nevada, United States

Nevada Cancer Institute
Las Vegas
Nevada
89135

New Jersey, United States

The Cancer Center At Hackensack University Medical Center
Hackensack
New Jersey
07601

New Jersey, United States

The Cancer Institute Of New Jersey
New Brunswick
New Jersey
08901

New York, United States

New York Presbyterian Hospital
New York
New York
10021

North Carolina, United States

The University Of North Carolina At Chapel Hill
Chapel Hill
North Carolina
27599

Ohio, United States

Cleveland Clinic Foundation
Cleveland
Ohio
44195

Oregon, United States

Oregon Health & Science University
Portland
Oregon
97239

Pennsylvania, United States

Western Pennsylvania Cancer Institute
Pittsburgh
Pennsylvania
15224

Tennessee, United States

Sarah Cannon Research Institute
Nashville
Tennessee
37203

Texas, United States

Ut Southwestern Medical Center
Dallas
Texas
75390

Texas, United States

The University Of Texas - M.D. Anderson Cancer Center
Houston
Texas
77030

Washington, United States

Seattle Cancer Care Alliance
Seattle
Washington
98109

Buenos Aires, Argentina

Local Institution
La Plata
Buenos Aires
1900

Argentina

Local Institution
Buenos Aires
1221

Argentina

Local Institution
Buenos Aires
1280

Argentina

Local Institution
Cordoba
5016

New South Wales, Australia

Local Institution
Camperdown
New South Wales
2050

New South Wales, Australia

Local Institution
St Leonards
New South Wales
2065

Queensland, Australia

Local Institution
South Brisbane
Queensland
4101

South Australia, Australia

Local Institution
Adelaide
South Australia
5000

Victoria, Australia

Local Institution
East Melbourne
Victoria
3002

Western Australia, Australia

Local Institution
Perth
Western Australia
WA 6000

Austria

Local Institution
Wien
1090

Belgium

Local Institution
B-Leuven
3000

Belgium

Local Institution
Brugge
8000

Belgium

Local Institution
Bruxelles
1000

Belgium

Local Institution
Charleroi
6000

Belgium

Local Institution
Edegem
2650

Belgium

Local Institution
Yvoir
5530

Parana, Brazil

Local Institution
Curitiba
Parana
80060

Sao Paulo, Brazil

Local Institution
Cep - Campinas
Sao Paulo
13083

Brazil

Local Institution
Rio De Janeiro
20230130

Brazil

Local Institution
Sao Paulo
05403

Brazil

Local Institution
Sao Paulo
05652

Alberta, Canada

Local Institution
Edmonton
Alberta
T6G 1Z2

Ontario, Canada

Local Institution
Hamilton
Ontario
L8N 3Z5

Quebec, Canada

Local Institution
Montreal
Quebec
H3A 1A1

Czech Republic

Local Institution
Brno
625 00

Czech Republic

Local Institution
Prague 2
128 20

Denmark

Local Institution
Aarhus C
8000

Denmark

Local Institution
Herlev
2730

Denmark

Local Institution
Odense C
5000

Finland

Local Institution
Helsinki
00029

France

Local Institution
Caen Cedex
14033

France

Local Institution
Creteil Cedex
94010

France

Local Institution
Grenoble Cedex 09
38043

France

Local Institution
Lille Cedex
59037

France

Local Institution
Marseille Cedex 9
13273

France

Local Institution
Nantes
44000

France

Local Institution
Paris Cedex 10
75475

France

Local Institution
Pierre Benite Cedex
69495

France

Local Institution
Poitiers Cedex
86021

France

Local Institution
Strasbourg
67091

France

Local Institution
Toulouse Cedex 09
31059

Germany

Local Institution
Dresden
01307

Germany

Local Institution
Frankfurt/Main
60590

Germany

Local Institution
Hamburg
20246

Germany

Local Institution
Leipzig
04103

Germany

Local Institution
Mainz
55131

Germany

Local Institution
Mannheim
68163

Hungary

Local Institution
Budapest
1097

Dublin, Ireland

Local Institution
Dublin 8
Dublin

Galway, Ireland

Local Institution
Co Galway
Galway

Israel

Local Institution
Ramat-Gan
52621

Italy

Local Institution
Bari
70124

Italy

Local Institution
Bologna
40138

Italy

Local Institution
Monza (Mi)
20052

Italy

Local Institution
Napoli
80131

Italy

Local Institution
Orbassano (To)
10043

Italy

Local Institution
Roma
00161

Italy

Local Institution
Roma
00144

Korea, Republic of

Local Institution
Jeollanam-Do

Korea, Republic of

Local Institution
Seoul
137-701

Korea, Republic of

Local Institution
Seoul
138-736

Distrito Federal, Mexico

Local Institution
Mexico
Distrito Federal
02990

Netherlands

Local Institution
Nijmegen
6525 GA

Netherlands

Local Institution
Rotterdam
3075 EA

Peru

Local Institution
Lima
LIMA II

Peru

Local Institution
Lima
34

Philippines

Local Institution
Quezon City
1102

Poland

Local Institution
Gdansk
80 211

Poland

Local Institution
Katowice
40032

Poland

Local Institution
Krakow
31501

Poland

Local Institution
Lodz
93510

Poland

Local Institution
Lublin
20 950

Poland

Local Institution
Warsaw
02097

Russian Federation

Local Institution
Moscow
125167

Russian Federation

Local Institution
St.Petersburg
197022

Singapore

Local Institution
Singapore
169608

Free State, South Africa

Local Institution
Bloemfontein
Free State
9301

Gauteng, South Africa

Local Institution
Groenkloof
Gauteng
0181

Gauteng, South Africa

Local Institution
Parktown
Gauteng
2193

Gauteng, South Africa

Local Institution
Soweto
Gauteng
2013

Western Cape, South Africa

Local Institution
Observatory
Western Cape
7925

Spain

Local Institution
Madrid
28006

Spain

Local Institution
Madrid
28034

Spain

Local Institution
Pamplona
31008

Sweden

Local Institution
Gothenburg
413 45

Sweden

Local Institution
Lund
22185

Sweden

Local Institution
Stockholm
171 76

Sweden

Local Institution
Umea
901 85

Sweden

Local Institution
Uppsala
751 85

Switzerland

Local Institution
Basel
4031

Taiwan

Local Institution
Taipei
100

Taiwan

Local Institution
Taoyuan
333

Cambridgeshire, United Kingdom

Local Institution
Cambridge
Cambridgeshire
CB2 2XY

Greater London, United Kingdom

Local Institution
London
Greater London
W12 OHS

Merseyside, United Kingdom

Local Institution
Liverpool
Merseyside
L7 8XP

Scotland, United Kingdom

Local Institution
Glasgow
Scotland
G12 OXB

Tyne And Wear, United Kingdom

Local Institution
Newcastle
Tyne And Wear
NE2 2DR

West Midlands, United Kingdom

Local Institution
Birmingham
West Midlands
B15 2TH
LinksBMS Clinical Trials Disclosure
Investigator Inquiry form
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
PublicationsPorkka K, Khoury HJ, Paquette RL, Matloub Y, Sinha R, Cortes JE. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer. 2010 Jan 15;116(2):377-86.

Müller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. Epub 2009 Sep 24.

Shah NP, Kantarjian HM, Kim DW, Réa D, Dorlhiac-Llacer PE, Milone JH, Vela-Ojeda J, Silver RT, Khoury HJ, Charbonnier A, Khoroshko N, Paquette RL, Deininger M, Collins RH, Otero I, Hughes T, Bleickardt E, Strauss L, Francis S, Hochhaus A. Intermittent target inhibition with dasatinib 100 mg once daily preserves efficacy and improves tolerability in imatinib-resistant and -intolerant chronic-phase chronic myeloid leukemia. J Clin Oncol. 2008 Jul 1;26(19):3204-12. Epub 2008 Jun 9.
Study ID numbersCA180-034
Last updatedFebruary 21, 2012
Record first receivedJuly 21, 2005
ClinicalTrials.gov identifierNCT00123474
Download dateInformation obtained from ClinicalTrials.gov on February 23, 2012
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