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

NCT00337454 | Completed Phase 1

• 1 other identifier: CA180-031
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 21

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)

Conditions

Chronic Myelogenous Leukemia

Keywords

Imatinib resistant or intolerant CML; Treatment resistant or intolerant Ph+ALL

Outcome Measures

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 (2)

• 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

Study Arms (6)

A1

EXPERIMENTAL

Drug: Dasatinib

A2

EXPERIMENTAL

Drug: Dasatinib

A3

EXPERIMENTAL

Drug: Dasatinib

B1

EXPERIMENTAL

Drug: Dasatinib

B2

EXPERIMENTAL

Drug: Dasatinib

B3

EXPERIMENTAL

Drug: Dasatinib

Interventions

Dasatinib DRUG

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

Also known as: Sprycel

A1

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (21)

Local Institution

Nagoya, Aichi-ken, 464-8681, Japan

Location

Local Institution

Nagoya, Aichi-ken, 466-8550, Japan

Location

Local Institution

Nagoya, Aichi-ken, 467-8602, Japan

Location

Local Institution

Maebashi, Gunma, 371-0821, Japan

Location

Local Institution

Nishinomiya-Shi, Hyōgo, 663-8501, Japan

Location

Local Institution

Kagoshima, Kagoshima-ken, 890-0064, Japan

Location

Local Institution

Isehara-Shi, Kanagawa, 259-1193, Japan

Location

Local Institution

Kanagawa, Kanagawa, Japan

Location

Local Institution

Kyoto, Kyoto, Japan

Location

Local Institution

Sendai, Miyagi, Japan

Location

Local Institution

Nagasaki, Nagasaki, Japan

Location

Local Institution

Okayama, Okayama-ken, 700-0082, Japan

Location

Local Institution

Moriguchi, Osaka, 570-8540, Japan

Location

Local Institution

Iruma-Gun, Saitama, 350-0495, Japan

Location

Local Institution

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Local Institution

Tochigi, Tochigi, 329-0498, Japan

Location

Local Institution

Bunkyo-Ku, Tokyo, 113-8677, Japan

Location

Local Institution

Chuo-Ku, Tokyo, 104-0045, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 160-8582, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 162-8666, Japan

Location

Local Institution

Tokyo, Tokyo, Japan

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 14, 2006
• First Posted: June 16, 2006
• Study Start: July 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: April 14, 2011

Record last verified: 2011-04

Locations

JP (21)