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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00349518
First received: July 6, 2006
Last updated: April 13, 2011
Last verified: April 2011

July 6, 2006
April 13, 2011
December 2006
January 2007   (final data collection date for primary outcome measure)
Incidence and severity of drug-related adverse events.
Same as current
Complete list of historical versions of study NCT00349518 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study of Dasatinib in Imatinib Resistant or Intolerant Subjects With Chronic or Advanced Phase CML or Philadelphia Chromosome Positive ALL
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

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
Drug: Dasatinib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
300
Not Provided
January 2007   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   Italy,   Netherlands,   Poland,   United Kingdom,   Hungary
 
NCT00349518
CA180-083, EUDRACTnr: 2006-001279-39
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