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

Primary Purpose

Chronic Myelogenous Leukemia

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Dasatinib
Dasatinib
Dasatinib
Dasatinib
Dasatinib
Dasatinib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring Imatinib resistant or intolerant CML, Treatment resistant or intolerant Ph+ALL

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Local Institution
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  • Local Institution
  • Local Institution
  • Local Institution
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  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A1

A2

A3

B1

B2

B3

Arm Description

Outcomes

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

Full Information

First Posted
June 14, 2006
Last Updated
April 7, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00337454
Brief Title
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia
Keywords
Imatinib resistant or intolerant CML, Treatment resistant or intolerant Ph+ALL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Title
A2
Arm Type
Experimental
Arm Title
A3
Arm Type
Experimental
Arm Title
B1
Arm Type
Experimental
Arm Title
B2
Arm Type
Experimental
Arm Title
B3
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel
Intervention Description
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Nagoya-Shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
Local Institution
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-0821
Country
Japan
Facility Name
Local Institution
City
Nishinomiya-Shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Local Institution
City
Kagoshima-Shi
State/Province
Kagoshima
ZIP/Postal Code
890-0064
Country
Japan
Facility Name
Local Institution
City
Isehara-Shi
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
Local Institution
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Local Institution
City
Nagasaki City
State/Province
Nagasaki
Country
Japan
Facility Name
Local Institution
City
Okayama-Shi
State/Province
Okayama
ZIP/Postal Code
700-0082
Country
Japan
Facility Name
Local Institution
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8540
Country
Japan
Facility Name
Local Institution
City
Iruma-Gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Local Institution
City
Hamamatsu-Shi
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Facility Name
Local Institution
City
Bunkyo-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8677
Country
Japan
Facility Name
Local Institution
City
Chuo-Ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Local Institution
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Local Institution
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Facility Name
Local Institution
City
Kanagawa
Country
Japan
Facility Name
Local Institution
City
Kyoto
Country
Japan
Facility Name
Local Institution
City
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Local Institution
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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