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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT00337454

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelogenous Leukemia	Drug: Dasatinib Drug: Dasatinib Drug: Dasatinib Drug: Dasatinib Drug: Dasatinib Drug: Dasatinib	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

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

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Nagoya-Shi	Aichi	Japan	467-8602
2	Local Institution	Nagoya	Aichi	Japan	464-8681
3	Local Institution	Nagoya	Aichi	Japan	466-8550
4	Local Institution	Maebashi	Gunma	Japan	371-0821
5	Local Institution	Nishinomiya-Shi	Hyogo	Japan	663-8501
6	Local Institution	Kagoshima-Shi	Kagoshima	Japan	890-0064
7	Local Institution	Isehara-Shi	Kanagawa	Japan	259-1193
8	Local Institution	Sendai	Miyagi	Japan
9	Local Institution	Nagasaki City	Nagasaki	Japan
10	Local Institution	Okayama-Shi	Okayama	Japan	700-0082
11	Local Institution	Moriguchi	Osaka	Japan	570-8540
12	Local Institution	Iruma-Gun	Saitama	Japan	350-0495
13	Local Institution	Hamamatsu-Shi	Shizuoka	Japan	431-3192
14	Local Institution	Bunkyo-Ku	Tokyo	Japan	113-8677
15	Local Institution	Chuo-Ku	Tokyo	Japan	104-0045
16	Local Institution	Shinjuku-Ku	Tokyo	Japan	160-8582
17	Local Institution	Shinjuku-Ku	Tokyo	Japan	162-8666
18	Local Institution	Kanagawa		Japan
19	Local Institution	Kyoto		Japan
20	Local Institution	Tochigi		Japan	329-0498
21	Local Institution	Tokyo		Japan