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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

NCT00337454 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-04-14

No results posted yet for this study

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

Interventions

DRUG

Dasatinib

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

DRUG

Dasatinib

Tablets, Oral, 70mg BID, once daily, 24 weeks.

DRUG

Dasatinib

Tablets, Oral, 90mg BID, once daily, 24 weeks.

DRUG

Dasatinib

Tablets, Oral, 70mg BID, once daily, 24 weeks.

DRUG

Dasatinib

Tablets, Oral, 70mg BID, once daily, 12 weeks.

DRUG

Dasatinib

Tablets, Oral, 70mg BID, once daily, 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00337454 on ClinicalTrials.gov