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:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00103701
First received: February 14, 2005
Last updated: April 13, 2011
Last verified: April 2011
  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
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: 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:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Blast Crisis
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014