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Advanced 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:
NCT00123487
First received: July 21, 2005
Last updated: April 30, 2012
Last verified: February 2012
History of Changes

July 21, 2005
April 30, 2012
June 2005
October 2006   (final data collection date for primary outcome measure)
To estimate the Complete Hematological Response rate of 70 and 140 mg of BMS-354825 in patients who have primary or acquired resistance to imatinib [ Time Frame: 81 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00123487 on ClinicalTrials.gov Archive Site
Progression free and overall survival [ Time Frame: 81 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
A Randomized Two-Arm, Multicenter, Open-Label Phase II Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

This is a phase II study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Myeloid Leukemia, Chronic, Accelerated Phase
  • Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
  • 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
606
April 2013
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with Ph+ (or BCR/ABL+) accelerated 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 of age 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
  • ECOG performance status score 0 - 2

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • 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
  • Prior therapy with BMS-35425
  • 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,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Netherlands,   Norway,   Peru,   Philippines,   Poland,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   United Kingdom
 
NCT00123487
CA180-035
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2012

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