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

February 16, 2016 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary
        • Local Institution
  • Italy
      • Bologna, Italy
        • Local Institution
      • Orbassano (To), Italy
        • Local Institution
      • Roma, Italy
        • Local Institution
  • Netherlands
      • Nijmegen, Netherlands
        • Local Institution
      • Rotterdam, Netherlands
        • Local Institution
  • Poland
      • Gdansk, Poland
        • Local Institution
      • Katowice, Poland
        • Local Institution
      • Krakow, Poland
        • Local Institution
      • Lodz, Poland
        • Local Instiution
      • Lublin, Poland
        • Local Institution
      • Warsaw, Poland
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation
        • Local Institution
      • St.Petersburg, Russian Federation
        • Local Institution
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom
        • Local Institution
    • Central
      • Glasgow, Central, United Kingdom
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom
        • Local Institution
    • Merseyside
      • Liverpool, Merseyside, United Kingdom
        • Local Institution
    • Tyne And Wear
      • Newcastle, Tyne And Wear, United Kingdom
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence and severity of drug-related adverse events.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 7, 2006

Study Record Updates

Last Update Posted (Estimate)

February 17, 2016

Last Update Submitted That Met QC Criteria

February 16, 2016

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-083
  • EUDRACTnr: 2006-001279-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe