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This study has been withdrawn prior to enrollment.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:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00349518
First received: July 6, 2006
Last updated: April 13, 2011
Last verified: April 2011
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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
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 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 May 16, 2013