EUCTR2006-001279-39-CZ
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subjects with Chronic or Advanced Phase Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) who are Resistant or Intolerant to Imatinib.
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Signed written informed consent
- •\- Subjects must have had prior exposure to imatinib and have primary or acquired resistance or intolerance. Subjects can be pretreated with IFN, standard chemotherapy or high\-dose chemotherapy and stem\-cell transplantation. Imatinib may or may not be their most recent treatment prior to entering this study.
- •Target population:
- •Subjects with a myeloproliferative disorder defined as Ph\+ CP CML must meet all the
- •following criteria:
- •\< 15% blasts in PB cells or BM
- •\< 30% blasts \+ promyelocytes in PB cells or BM
- •\< 20% basophils in PB cells
- •Platelets \= 100,000/mm³ (or less if related to prior drug therapy)
- •No extra\-medullar involvement (except liver or spleen)
Exclusion Criteria
- •1\) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least one month before and for at least 3 months after completion of the study medication.
- •2\) WOCBP using a non\-effective contraceptive method
- •3\) Women who are pregnant or breastfeeding
- •4\) Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •5\) Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 3 months after completion of study medication.
- •Medical History and Concurrent Diseases
- •6\) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
- •7\) Uncontrolled or significant cardiovascular disease, including:
- •A myocardial infarction within 6 months
- •Uncontrolled angina within 3 months
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
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 ImatinibSubjects with Chronic or Advanced Phase Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) who are Resistant or Intolerant to Imatinib.EUCTR2006-001279-39-BEBristol-Myers Squibb International Corporation300
Active, not recruiting
Not Applicable
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. - NDChronic phase,accelerated phase, myeloid and lymphoid phase chronic myeloid leukemia and Ph ALL who are resistan or intolerant to ImatinibMedDRA version: 8.1Level: HLGTClassification code 10024324Term: LeukaemiasEUCTR2006-001279-39-ITBristol Myers Squibb International Corporation300
Active, not recruiting
Not Applicable
Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/neu-Positive Breast CancerRevised Protocol 02 incorporating amendments 03 and 04+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 dated 16-Aug-06)+ Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)Women with recurrent or progressive locally-advanced or metastatic breast cancerEUCTR2006-002178-23-BEBristol-Myers Squibb International Corporation80
Active, not recruiting
Phase 1
Phase II Study of Dasatinib (BMS-354825) for Advanced ‘Triple-negative’ Breast Cancer+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 2.0 dated 16-Aug-06)+ Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)Recurrent or progressive locally-advanced or metastatic 'triple-negative' breast cancerEUCTR2006-002045-36-FRBristol-Myers Squibb International Corporation45
Active, not recruiting
Phase 1
Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/neu-Positive Breast Cancer+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific (version 1.0 dated 16-Aug-06)+ Pharmacogenomics Tissue Sample Amendment Number 02 - Site Specific - (version 1.0 dated 16-Aug-06)EUCTR2006-002178-23-FRBristol-Myers Squibb International Corporation80