Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064233
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-07-08
Brief Title:
BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Dose-Escalation Study To Determine The Safety Pharmacokinetics And Pharmacodynamics Of BMS-354825 In The Treatment Of Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Hematologic Resistance To Imatinib Mesylate Gleevec
Status:
COMPLETED
Status Verified Date:
2012-08
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:
RATIONALE BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth
PURPOSE This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate
PURPOSE This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose maximum administered dose dose-limiting toxicity and a recommended phase II dose of BMS-354825 in patients with chronic phase chronic myelogenous leukemia who have hematologic resistance to imatinib mesylate
Determine the safety and tolerability of this drug in these patients
Determine the plasma pharmacokinetics of this drug in these patients
Determine preliminarily the efficacy of this drug in terms of hematologic cytogenetic and molecular responses in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral BMS-354825 once daily on days 1-5 Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity Patients may receive further treatment in the absence of disease progression
Cohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Once the MTD is determined 20 additional patients receive treatment as in phase I at the MTD of BMS-354825
Patients are followed for at least 30 days
PROJECTED ACCRUAL Approximately 50 patients 30 for phase I and 20 for phase II will be accrued for this study within 12-18 months
Determine the maximum tolerated dose maximum administered dose dose-limiting toxicity and a recommended phase II dose of BMS-354825 in patients with chronic phase chronic myelogenous leukemia who have hematologic resistance to imatinib mesylate
Determine the safety and tolerability of this drug in these patients
Determine the plasma pharmacokinetics of this drug in these patients
Determine preliminarily the efficacy of this drug in terms of hematologic cytogenetic and molecular responses in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral BMS-354825 once daily on days 1-5 Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity Patients may receive further treatment in the absence of disease progression
Cohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
Once the MTD is determined 20 additional patients receive treatment as in phase I at the MTD of BMS-354825
Patients are followed for at least 30 days
PROJECTED ACCRUAL Approximately 50 patients 30 for phase I and 20 for phase II will be accrued for this study within 12-18 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BMS-CA180002 | None | None | None |
| UCLA-0303035 | None | None | None |