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Completed

NCT Number: NCT00337454

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

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)

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Key information

Conditions

Chronic Myelogenous Leukemia Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution, Nagoya, Aichi-ken, Japan

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

Tablets, Oral, 50mg BID, once daily, 24 weeks.

Other names: Sprycel

Primary outcomes

  1. 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 outcomes

  1. 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

  2. response

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jun 16, 2006
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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