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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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