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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 FoundationCleveland, Ohio  44195
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Washington University School of MedicineSaint Louis, Missouri  63110
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Emory University School of MedicineAtlanta, Georgia  30322
Georgia Cancer SpecialistsDecatur, Georgia  30033
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
Seattle Cancer Care AllianceSeattle, Washington  98109
Pacific Shores Medical GroupLong Beach, California  90813
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Oregon Health & Science UniversityPortland, Oregon  97201
University of FloridaGainesville, Florida  32610-0277
Nebraska Methodist HospitalOmaha, Nebraska  68114
Kaiser Permanente Medical CenterVallejo, California  94589
University of MarylandBaltimore, Maryland  21201
University of KentuckyLexington, Kentucky  40536-0098
Ventura County Hematology-Oncology SpecialistsOxnard, California  93030
University of MiamiMiami, Florida  33136
New York Presbyterian HospitalNew York, New York  10021
Northwestern University Feinberg School of MedicineChicago, Illinois  60611
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
The University of ChicagoChicago, Illinois  60637
Oncology Hematology Associates of Central Illinois, PCPeoria, Illinois  61602
Nevada Cancer InstituteLas Vegas, Nevada  89135
Ut Southwestern Medical CenterDallas, Texas  75390
Local InstitutionChattanooga, Tennessee  
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Karmanos Cancer CenterDetroit, Michigan  48201
Central Hematology Oncology Medical Group Inc.Alhambra, California  91801
Pacific Cancer Medical Center IncAnaheim, California  92801
Loma Linda University Cancer CenterLoma Linda, California  92354
Suburban Hematology-Oncology Associates, PcLawrenceville, Georgia  30046
Devetten, MarcelOmaha, Nebraska  68198
Ucla Dept. Of MedicineLos Angeles, California  90095
Dana Faber Cancer InstituteBoston, Massachusetts  02115
Georgetown University Med CtrWashington, District of Columbia  20007