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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Chronic Myeloid Leukemia
Acute Lymphoblastic Leukemia
Drug: Dasatinib
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Incidence and severity of drug-related adverse events.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: December 2006
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349518

Locations
Hungary
Local Institution
Budapest, Hungary
Italy
Local Institution
Bologna, Italy
Local Institution
Orbassano (To), Italy
Local Institution
Roma, Italy
Netherlands
Local Institution
Nijmegen, Netherlands
Local Institution
Rotterdam, Netherlands
Poland
Local Institution
Gdansk, Poland
Local Institution
Katowice, Poland
Local Institution
Krakow, Poland
Local Instiution
Lodz, Poland
Local Institution
Lublin, Poland
Local Institution
Warsaw, Poland
Russian Federation
Local Institution
Moscow, Russian Federation
Local Institution
St.Petersburg, Russian Federation
United Kingdom
Local Institution
Cambridge, Cambridgeshire, United Kingdom
Local Institution
Glasgow, Central, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
Liverpool, Merseyside, United Kingdom
Local Institution
Newcastle, Tyne And Wear, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00349518     History of Changes
Other Study ID Numbers: CA180-083, EUDRACTnr: 2006-001279-39
Study First Received: July 6, 2006
Last Updated: April 13, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Chronic and Advanced Phase CML and
Philadelphia Chromosome Positive ALL with imatinib intolerance or resistance

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Abnormal Karyotype
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib
Dasatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014