Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00123474
First received: July 21, 2005
Last updated: January 22, 2014
Last verified: January 2014

July 21, 2005
January 22, 2014
July 2005
September 2006   (final data collection date for primary 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 [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00123474 on ClinicalTrials.gov Archive Site
  • Progression free and overall survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Comparison of Major Cytogenetic Response rate between two dose levels [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
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)

This 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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myeloid Leukemia, Chronic, Chronic-Phase
  • Drug: dasatinib
    Tablets, Oral, 50 mg BID, indefinitely, survival study
    Other Names:
    • Sprycel
    • BMS-354825
  • Drug: dasatinib
    Tablets, Oral, 70 mg BID, indefinitely, survival study
    Other Names:
    • Sprycel
    • BMS-354825
  • Drug: dasatinib
    Tablets, Oral, 100 mg QD, indefinitely, survival study
    Other Names:
    • Sprycel
    • BMS-354825
  • Drug: dasatinib
    Tablets, Oral, 140 mg QD, indefinitely, survival study
    Other Names:
    • Sprycel
    • BMS-354825
  • Experimental: 1
    Intervention: Drug: dasatinib
  • Experimental: 2
    Intervention: Drug: dasatinib
  • Experimental: 3
    Intervention: Drug: dasatinib
  • Experimental: 4
    Intervention: Drug: dasatinib

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
670
June 2014
September 2006   (final data collection date for primary outcome measure)

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Norway,   Peru,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
 
NCT00123474
CA180-034
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP