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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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00337454
First received: June 14, 2006
Last updated: April 7, 2011
Last verified: April 2011
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A1 Drug: Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
Other Name: Sprycel
Experimental: A2 Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Name: Sprycel
Experimental: A3 Drug: Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
Other Name: Sprycel
Experimental: B1 Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
Other Name: Sprycel
Experimental: B2 Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Name: Sprycel
Experimental: B3 Drug: Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
Other Name: Sprycel

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Local Institution
Nagoya, Aichi, Japan, 466-8550
Local Institution
Nagoya, Aichi, Japan, 464-8681
Local Institution
Nagoya-Shi, Aichi, Japan, 467-8602
Local Institution
Maebashi, Gunma, Japan, 371-0821
Local Institution
Nishinomiya-Shi, Hyogo, Japan, 663-8501
Local Institution
Kagoshima-Shi, Kagoshima, Japan, 890-0064
Local Institution
Isehara-Shi, Kanagawa, Japan, 259-1193
Local Institution
Sendai, Miyagi, Japan
Local Institution
Nagasaki City, Nagasaki, Japan
Local Institution
Okayama-Shi, Okayama, Japan, 700-0082
Local Institution
Moriguchi, Osaka, Japan, 570-8540
Local Institution
Iruma-Gun, Saitama, Japan, 350-0495
Local Institution
Hamamatsu-Shi, Shizuoka, Japan, 431-3192
Local Institution
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
Kanagawa, Japan
Local Institution
Kyoto, Japan
Local Institution
Tochigi, Japan, 329-0498
Local Institution
Tokyo, Japan
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00337454     History of Changes
Other Study ID Numbers: CA180-031
Study First Received: June 14, 2006
Last Updated: April 7, 2011
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Philadelphia Chromosome
Bone Marrow Diseases
Chromosome Aberrations
Hematologic Diseases
Myeloproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Translocation, Genetic
Dasatinib
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014