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Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00349518
Recruitment Status : Withdrawn
First Posted : July 7, 2006
Last Update Posted : February 17, 2016
Sponsor:
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE July 6, 2006
First Posted Date  ICMJE July 7, 2006
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE December 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2006)
Incidence and severity of drug-related adverse events.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2006)
  • Chronic Phase CML: Cytogenetic and Hematologic Response
  • Advanced Phase CML and Philadelphia positive ALL: Hematologic Response
  • Time to and duration of Cytogenetic and Hematologic Response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
Official Title  ICMJE A Phase II Study of Dasatinib (BMS-354825) in Subjects With Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib
Brief Summary The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
Intervention  ICMJE Drug: Dasatinib
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: February 16, 2016)
0
Original Enrollment  ICMJE
 (submitted: July 6, 2006)
300
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females, 18 or older
  • CP or AD CML or Ph+ ALL
  • Intolerant of resistant to imatinib
  • ECOG PS 0-2 (CP CML)
  • ECOG PS 0-3 (AD CML and Ph+ ALL)
  • Adequate hepatic and renal function

Exclusion Criteria:

  • Pregnant or breastfeeding females
  • History of significant cardiac disease
  • History of significant bleeding disorder (not CML)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Italy,   Netherlands,   Poland,   Russian Federation,   United Kingdom
Removed Location Countries Austria,   Belgium,   Czech Republic,   Denmark,   Finland,   Germany,   Greece,   Ireland,   Norway,   Spain,   Sweden,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00349518
Other Study ID Numbers  ICMJE CA180-083
EUDRACTnr: 2006-001279-39
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2011

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