BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00103701
First received: February 14, 2005
Last updated: April 13, 2011
Last verified: April 2011
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Purpose
The purpose of this clinical research study is to understand the safety and efficacy of BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of imatinib mesylate (Gleevec).
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myeloid, Chronic-phase Leukemia, Lymphoblastic, Acute, Philadelphia-positive |
Drug: Dasatinib |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Establishment of MTD and recommended Phase II dose.
Secondary Outcome Measures:
- 1) Hematologic Response 2) Cytogenetic Response.
| Study Start Date: | November 2003 |
| Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Dasatinib
Tablets, Oral, 15- 240 mg, Once or twice daily, 0-3 years depending on response.
Other Name: Sprycel
|
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase BML or ALL.
- Patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate.
- Men and women, 14 years of age or older.
- Adequate renal function.
- Adequate hepatic function.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
Exclusion Criteria:
- Patients who are eligible and willing to undergo transplantation during the screening period.
- Women who are pregnant or breastfeeding.
- A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- Uncontrolled or significant cardiovascular disease.
- Medications that increase bleeding risk.
- Medications that change heart rhythms.
- Dementia or altered mental status that would prohibit the understanding of rendering of informed consent.
- History of significant bleeding disorder or unrelated to CML.
- Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103701
Locations
| United States, California | |
| Local Institution | |
| Los Angeles, California, United States | |
| United States, Texas | |
| Local Institution | |
| Houston, Texas, United States | |
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: | NCT00103701 History of Changes |
| Other Study ID Numbers: | CA180-002 |
| Study First Received: | February 14, 2005 |
| Last Updated: | April 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bristol-Myers Squibb:
|
Chronic myelogenous leukemia (CML) chronic, accelerated, blast phase Philadelphia chromosome positive acute (Ph+ALL) |
Additional relevant MeSH terms:
|
Blast Crisis Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Neoplasms by Histologic Type Neoplasms Cell Transformation, Neoplastic Neoplastic Processes Myeloproliferative Disorders |
Bone Marrow Diseases Hematologic Diseases Pathologic Processes Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dasatinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013