Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337454
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2006-06-14
Brief Title:
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or PhAll in Japan
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase III 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
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PhALL
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None