Korean Early Access Program - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00454753

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

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate Dasatinib

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

Study Start Date:

May 2007

Intervention Details:

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

the time of reimbursement in Korea
the application for marketing authorization is withdrawn
the application for marketing authorization is denied

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454753

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

Bristol-Myers Squibb, Korea

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-109
Study First Received:	March 30, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00454753
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Myeloid, Chronic
Lymphocytic, Acute

Study placed in the following topic categories:

Philadelphia Chromosome
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid

Imatinib
Leukemia
Lymphatic Diseases
Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoproliferative Disorders
Bone Marrow Diseases
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009