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

Chronic Myelogenous Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337454
• Other study ID #: CA180-031
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 14, 2006
• Last updated: April 7, 2011
• Start date: July 2005
• Est. completion date: March 2007

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Philadelphia Chromosome

Intervention

Drug:
• Dasatinib
Tablets, Oral, 50mg BID, once daily, 24 weeks.
• Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
• Dasatinib
Tablets, Oral, 90mg BID, once daily, 24 weeks.
• Dasatinib
Tablets, Oral, 70mg BID, once daily, 24 weeks.
• Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.
• Dasatinib
Tablets, Oral, 70mg BID, once daily, 12 weeks.

Locations

Country	Name	City	State
Japan	Local Institution	Bunkyo-Ku	Tokyo
Japan	Local Institution	Chuo-Ku	Tokyo
Japan	Local Institution	Hamamatsu-Shi	Shizuoka
Japan	Local Institution	Iruma-Gun	Saitama
Japan	Local Institution	Isehara-Shi	Kanagawa
Japan	Local Institution	Kagoshima-Shi	Kagoshima
Japan	Local Institution	Kanagawa
Japan	Local Institution	Kyoto
Japan	Local Institution	Maebashi	Gunma
Japan	Local Institution	Moriguchi	Osaka
Japan	Local Institution	Nagasaki City	Nagasaki
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Nagoya	Aichi
Japan	Local Institution	Nagoya-Shi	Aichi
Japan	Local Institution	Nishinomiya-Shi	Hyogo
Japan	Local Institution	Okayama-Shi	Okayama
Japan	Local Institution	Sendai	Miyagi
Japan	Local Institution	Shinjuku-Ku	Tokyo
Japan	Local Institution	Shinjuku-Ku	Tokyo
Japan	Local Institution	Tochigi
Japan	Local Institution	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	response

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm