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A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00866736
First Posted: March 20, 2009
Last Update Posted: September 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Epidemiological and Clinical Research Information Network
Information provided by:
Kanto CML Study Group
  Purpose
The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.

Condition Intervention Phase
Chronic Myeloid Leukemia Drug: dasatinib Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia

Resource links provided by NLM:


Further study details as provided by Kanto CML Study Group:

Primary Outcome Measures:
  • rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects [ Time Frame: at 12 months ]

Secondary Outcome Measures:
  • safety after treatment with dasatinib [ Time Frame: 2 year ]
  • rate of Complete Cytogenetic Response(CCyR) [ Time Frame: 2 year ]
  • rate of Complete Hematologic Response (CHR) [ Time Frame: 2 year ]
  • efficacy on patients with BCR-ABL point mutations [ Time Frame: 2 year ]
  • progression free survival [ Time Frame: 2 year ]

Enrollment: 65
Study Start Date: March 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dasatinib Drug: dasatinib
100mg QD
Other Name: BMS-354825

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Written Informed Consent
  • Subjects with chronic phase chronic myeloid leukemia (CML)
  • Subjects resistant/intolerant to imatinib
  • Subjects presenting:

    1. ECOG performance status (PS) score 0-2
    2. Adequate hepatic function
    3. Adequate renal function
    4. Adequate lung function

Exclusion Criteria:

  • Concurrent malignancy other than CML
  • Women who are pregnant or breastfeeding
  • Concurrent pleural effusion
  • Uncontrolled or significant cardiovascular disease
  • A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
  • Prior therapy with dasatinib
  • Subjects with T315I and/or F317L BCR-ABL point mutations
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00866736


Locations
Japan
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
Sponsors and Collaborators
Kanto CML Study Group
Epidemiological and Clinical Research Information Network
Investigators
Principal Investigator: Hisashi Sakamaki, MD.PhD Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hisashi Sakamaki, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
ClinicalTrials.gov Identifier: NCT00866736     History of Changes
Other Study ID Numbers: KCSG-01
First Submitted: March 18, 2009
First Posted: March 20, 2009
Last Update Posted: September 15, 2015
Last Verified: December 2010

Keywords provided by Kanto CML Study Group:
chronic myeloid leukemia
dasatinib
chronic phase myeloid leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Dasatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action