Korean Early Access Program

This treatment has been approved for sale to the public.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00454753
First received: March 30, 2007
Last updated: May 7, 2010
Last verified: May 2010
  Purpose

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 Intervention
Leukemia
Drug: Dasatinib

Study Type: Expanded Access     What is 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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 the application for marketing authorization is withdrawn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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: 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, 705-825
Local Institution
Daegu, Korea, Republic of, 705-030
Local Institution
Daegu, Korea, Republic of, 700-721
Local Institution
Daegu, Korea, Republic of, 700-310
Local Institution
Daegu, Korea, Republic of, 701-600
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, 130-050
Local Institution
Seoul, Korea, Republic of, 134-060
Local Institution
Seoul, Korea, Republic of, 136-705
Local Institution
Seoul, Korea, Republic of, 120-752
Local Institution
Seoul, Korea, Republic of, 135-710
Local Institution
Seoul, Korea, Republic of, 158-710
Local Institution
Seoul, Korea, Republic of, 134-701
Local Institution
Seoul, Korea, Republic of, 137-701
Local Institution
Seoul, Korea, Republic of, 110-744
Local Institution
Seoul, Korea, Republic of, 150-713
Local Institution
Seoul, Korea, Republic of, 138-736
Local Institution
Ulsan, Korea, Republic of, 682-061
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb, Korea
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00454753     History of Changes
Other Study ID Numbers: CA180-109
Study First Received: March 30, 2007
Last Updated: May 7, 2010
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014