Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00337454

Purpose

This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Condition	Intervention	Phase
Chronic Myelogenous Leukemia	Drug: Dasatinib	Phase I Phase II

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

Drug Information available for: Imatinib Imatinib mesylate Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Evaluate the safety of BMS-354825 administered orally twice daily for 4 weeks, evaluate the efficacy of BMS-354825 as defined by cytogenetic response for subjects with chronic phase CML, and as defined by hematologic response

Secondary Outcome Measures:

Pharmacokinetic profiles, cytogenetic response and hematologic response, BCR-ABL point mutations and biochemical assays of BCR-ABL, safety, time to and duration of hematologic and cytogenetic response
response

Estimated Enrollment:	48
Study Start Date:	July 2005

Arms	Assigned Interventions
A1: Experimental	Drug: Dasatinib Tablets, Oral, 50mg BID, once daily, 24 weeks.
A2: Experimental	Drug: Dasatinib Tablets, Oral, 70mg BID, once daily, 24 weeks.
A3: Experimental	Drug: Dasatinib Tablets, Oral, 90mg BID, once daily, 24 weeks.
B1: Experimental	Drug: Dasatinib Tablets, Oral, 70mg BID, once daily, 24 weeks.
B2: Experimental	Drug: Dasatinib Tablets, Oral, 70mg BID, once daily, 12 weeks.
B3: Experimental	Drug: Dasatinib Tablets, Oral, 70mg BID, once daily, 12 weeks.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Philadelphia chromosome positive or bcr-abl gene positive
Chronic Myelogenous Leukemia (CML)
Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
Men and women, ages 20 - 75
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

Subjects who are eligible and willing to undergo transplantation at pre-study
Women who are pregnant or breastfeeding
Uncontrolled or significant cardiovascular disease
History of significant bleeding disorder unrelated to CML or ALL
Adequate hepatic function
Adequate renal function
Medication that increase bleeding risk
Medication that change heart rhythms
Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00337454

Locations

Japan
Local Institution
Kanagawa, Japan, --
Local Institution
Kyoto, Japan, --
Local Institution
Tochigi, Japan, 329-0498
Local Institution
Tokyo, Japan, --
Japan, Aichi
Local Institution
Nagoya, Aichi, Japan, 466-8550
Local Institution
Nagoya-Shi, Aichi, Japan, 467-8602
Local Institution
Nagoya, Aichi, Japan, 464-8681
Japan, Gunma
Local Institution
Maebashi, Gunma, Japan, 371-0821
Japan, Hyogo
Local Institution
Nishinomiya-Shi, Hyogo, Japan, 663-8501
Japan, Kagoshima
Local Institution
Kagoshima-Shi, Kagoshima, Japan, 890-0064
Japan, Kanagawa
Local Institution
Isehara-Shi, Kanagawa, Japan, 259-1193
Japan, Miyagi
Local Institution
Sendai, Miyagi, Japan, --
Japan, Nagasaki
Local Institution
Nagasaki City, Nagasaki, Japan, --
Japan, Okayama
Local Institution
Okayama-Shi, Okayama, Japan, 700-0082
Japan, Osaka
Local Institution
Moriguchi, Osaka, Japan, 570-8540
Japan, Saitama
Local Institution
Iruma-Gun, Saitama, Japan, 350-0495
Japan, Shizuoka
Local Institution
Hamamatsu-Shi, Shizuoka, Japan, 431-3192
Japan, Tokyo
Local Institution
Chuo-Ku, Tokyo, Japan, 104-0045
Local Institution
Bunkyo-Ku, Tokyo, Japan, 113-8677
Local Institution
Shinjuku-Ku, Tokyo, Japan, 162-8666
Local Institution
Shinjuku-Ku, Tokyo, Japan, 160-8582

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

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

Study ID Numbers:	CA180-031
Study First Received:	June 14, 2006
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00337454
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bristol-Myers Squibb:

Imatinib resistant or intolerant CML
Treatment resistant or intolerant Ph+ALL

Study placed in the following topic categories:

Chromosomal abnormalities
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
Chromosome Aberrations
Lymphoproliferative Disorders
Bone Marrow Diseases
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Translocation, Genetic

ClinicalTrials.gov processed this record on January 16, 2009