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A 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)


Phase 3
18 Years
90 Years
Open (Enrolling)
Both
Myeloid Leukemia, Chronic, Chronic-Phase

Thank you

Trial Information

A 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)


For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To 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

Outcome Time Frame:

throughout the study

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA180-034

NCT ID:

NCT00123474

Start Date:

July 2005

Completion Date:

June 2014

Related Keywords:

  • Myeloid Leukemia, Chronic, Chronic-Phase
  • Chronic Phase Chronic Myelogenous Leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid, Chronic-Phase
  • Philadelphia Chromosome
  • Chronic Disease

Name

Location

Cleveland Clinic Foundation Cleveland, Ohio  44195
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Washington University School of Medicine Saint Louis, Missouri  63110
MD Anderson Cancer Center Orlando Orlando, Florida  32806
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Washington Cancer Institute at Washington Hospital Center Washington, District of Columbia  20010
Emory University School of Medicine Atlanta, Georgia  30322
Georgia Cancer Specialists Decatur, Georgia  30033
Western Pennsylvania Cancer Institute Pittsburgh, Pennsylvania  15224
Seattle Cancer Care Alliance Seattle, Washington  98109
Pacific Shores Medical Group Long Beach, California  90813
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Oregon Health & Science University Portland, Oregon  97201
University of Florida Gainesville, Florida  32610-0277
Nebraska Methodist Hospital Omaha, Nebraska  68114
Kaiser Permanente Medical Center Vallejo, California  94589
University of Maryland Baltimore, Maryland  21201
University of Kentucky Lexington, Kentucky  40536-0098
Ventura County Hematology-Oncology Specialists Oxnard, California  93030
University of Miami Miami, Florida  33136
New York Presbyterian Hospital New York, New York  10021
Northwestern University Feinberg School of Medicine Chicago, Illinois  60611
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
The University of Chicago Chicago, Illinois  60637
Oncology Hematology Associates of Central Illinois, PC Peoria, Illinois  61602
Nevada Cancer Institute Las Vegas, Nevada  89135
Ut Southwestern Medical Center Dallas, Texas  75390
Local Institution Chattanooga, Tennessee  
The Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
University of North Carolina at Chapel Hill Chapel Hill, North Carolina  27599
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
Karmanos Cancer Center Detroit, Michigan  48201
Central Hematology Oncology Medical Group Inc. Alhambra, California  91801
Pacific Cancer Medical Center Inc Anaheim, California  92801
Loma Linda University Cancer Center Loma Linda, California  92354
Suburban Hematology-Oncology Associates, Pc Lawrenceville, Georgia  30046
Devetten, Marcel Omaha, Nebraska  68198
Ucla Dept. Of Medicine Los Angeles, California  90095
Dana Faber Cancer Institute Boston, Massachusetts  02115
Georgetown University Med Ctr Washington, District of Columbia  20007