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Korean Early Access Program

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ClinicalTrials.gov Identifier: NCT00454753
Recruitment Status : Approved for marketing
First Posted : April 2, 2007
Last Update Posted : May 12, 2010
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:
This protocol allows CML and Ph+ ALL subjects who are resistant to or intolerant of imatinib mesylate, to potentially benefit from dasatinib. It is intended to provide patients with access to dasatinib while awaiting reimbursement decision in Korea and it will also provide additional data on the safety of dasatinib in Korean population

Condition or disease Intervention/treatment
Leukemia Drug: Dasatinib

Study Type : Expanded Access
Official Title: Study of Dasatinib (BMS-354825) in Subjects With Chronic Phase or Advanced Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Who Are Resistant to or Intolerant of Imatinib Mesylate
Study Start Date : May 2007



Intervention Details:
    Drug: Dasatinib

    tablet, Oral, 140mg/day, BID, until;

    1. the time of reimbursement in Korea
    2. the application for marketing authorization is withdrawn
    3. the application for marketing authorization is denied
    Other Names:
    • Sprycel
    • BMS-354825

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Clinical diagnosis of CML or Ph+ ALL who have primary or acquired resistance to or intolerance of imatinib mesylate
  • ECOG performance status score 0 - 2
  • Adequate hepatic, renal function

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): NCT00454753


Locations
Korea, Republic of
Local Institution
Busan, Korea, Republic of, 602-702
Local Institution
Busan, Korea, Republic of, 602-739
Local Institution
Daegu, Korea, Republic of, 700-310
Local Institution
Daegu, Korea, Republic of, 700-721
Local Institution
Daegu, Korea, Republic of, 701-600
Local Institution
Daegu, Korea, Republic of, 705-030
Local Institution
Daegu, Korea, Republic of, 705-825
Local Institution
Daejeon, Korea, Republic of, 301-721
Local Institution
Gyeonggi-do, Korea, Republic of, 431-070
Local Institution
Incheon, Korea, Republic of, 400-711
Local Institution
Jellanamdo, Korea, Republic of, 519-809
Local Institution
Jeollabuk-do, Korea, Republic of, 561-712
Local Institution
Seoul, Korea, Republic of, 110-744
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 130-050
Local Institution
Seoul, Korea, Republic of, 134-060
Local Institution
Seoul, Korea, Republic of, 134-701
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Seoul, Korea, Republic of, 136-705
Local Institution
Seoul, Korea, Republic of, 137-701
Local Institution
Seoul, Korea, Republic of, 138-736
Local Institution
Seoul, Korea, Republic of, 150-713
Local Institution
Seoul, Korea, Republic of, 158-710
Local Institution
Ulsan, Korea, Republic of, 682-061
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb, Korea

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00454753     History of Changes
Other Study ID Numbers: CA180-109
First Posted: April 2, 2007    Key Record Dates
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Bristol-Myers Squibb:
Myeloid, Chronic
Lymphocytic, Acute

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