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

April 7, 2011 updated by: Bristol-Myers Squibb

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A1
Drug: Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Names:
  • Sprycel
Experimental: A2
Drug: Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Names:
  • Sprycel
Experimental: A3
Drug: Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Names:
  • Sprycel
Experimental: B2
Drug: Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Names:
  • Sprycel
Experimental: B3
Drug: Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Names:
  • Sprycel
Experimental: B1
Drug: Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Other Names:
  • Sprycel
Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Names:
  • Sprycel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
response
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

June 14, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (Estimate)

June 16, 2006

Study Record Updates

Last Update Posted (Estimate)

April 14, 2011

Last Update Submitted That Met QC Criteria

April 7, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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