Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00337454
First received: June 14, 2006
Last updated: April 7, 2011
Last verified: April 2011

June 14, 2006
April 7, 2011
July 2005
March 2007   (final data collection date for primary outcome measure)
Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response
Same as current
Complete list of historical versions of study NCT00337454 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response
  • response
Same as current
Not Provided
Not Provided
 
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment

This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Myelogenous Leukemia
  • Drug: Dasatinib
    Tablets, Oral, 50mg BID, once daily, 24 weeks.
    Other Name: Sprycel
  • Drug: Dasatinib
    Tablets, Oral, 70mg BID, once daily, 24 weeks.
    Other Name: Sprycel
  • Drug: Dasatinib
    Tablets, Oral, 90mg BID, once daily, 24 weeks.
    Other Name: Sprycel
  • Drug: Dasatinib
    Tablets, Oral, 70mg BID, once daily, 12 weeks.
    Other Name: Sprycel
  • Experimental: A1
    Intervention: Drug: Dasatinib
  • Experimental: A2
    Intervention: Drug: Dasatinib
  • Experimental: A3
    Intervention: Drug: Dasatinib
  • Experimental: B1
    Intervention: Drug: Dasatinib
  • Experimental: B2
    Intervention: Drug: Dasatinib
  • Experimental: B3
    Intervention: Drug: Dasatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Philadelphia chromosome positive or bcr-abl gene positive
  • Chronic Myelogenous Leukemia (CML)
  • Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
  • Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
  • Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
  • Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
  • Men and women, ages 20 - 75
  • Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

  • Subjects who are eligible and willing to undergo transplantation at pre-study
  • Women who are pregnant or breastfeeding
  • Uncontrolled or significant cardiovascular disease
  • History of significant bleeding disorder unrelated to CML or ALL
  • Adequate hepatic function
  • Adequate renal function
  • Medication that increase bleeding risk
  • Medication that change heart rhythms
  • Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Both
20 Years to 75 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00337454
CA180-031
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
April 2011

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