Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112775
Status:
UNKNOWN
Last Update Posted:
2011-06-07
First Post:
2005-06-02
Brief Title:
BMS-354825 or Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Previous Imatinib Mesylate
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Multi-Center Open Label Study of BMS-354825 vs Imatinib Mesylate Gleevec 800 mgd in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Iamtinib at a Dose of 400-600 mgd
Status:
UNKNOWN
Status Verified Date:
2006-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
PURPOSE This randomized phase II trial is studying BMS-354825 to see how well it works compared to imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia that did not respond to previous imatinib mesylate
PURPOSE This randomized phase II trial is studying BMS-354825 to see how well it works compared to imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia that did not respond to previous imatinib mesylate
Detailed Description:
OBJECTIVES
Primary
Determine the 12-week major cytogenetic response MCyR rate in patients with imatinib mesylate-resistant Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia treated with BMS-354825 vs imatinib mesylate
Secondary
Determine the MCyR rate prior to crossover in patients treated with these drugs
Determine the durability of MCyR and time to MCyR prior to crossover in patients treated with these drugs
Determine the complete hematologic response CHR rate prior to crossover in patients treated with these drugs
Determine the durability of CHR and time to CHR prior to crossover in patients treated with these drugs
Determine the major molecular response rate prior to crossover as determined by BCR-ABL transcripts in blood during treatment using quantitative reverse transcriptase polymerase chain reaction in patients treated with these drugs
Determine post-crossover efficacy endpoints in patients treated with these drugs who crossover
Assess health-related quality of life prior to crossover in patients treated with these drugs
Determine the safety and tolerability of BMS-354825 in these patients
Determine the pharmacokinetics of BMS-354825 in these patients
OUTLINE This is an open-label multicenter randomized crossover study Patients are stratified according to study site and cytogenetic response to prior imatinib mesylate yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral BMS-354825 twice daily in the absence of disease progression or unacceptable toxicity Patients experiencing disease progression or persistent intolerance to BMS-354825 cross over to arm II after a 2-day washout period After crossover patients receive oral imatinib mesylate twice daily in the absence of further disease progression or unacceptable toxicity
Arm II Patients receive oral imatinib mesylate twice daily in the absence of disease progression or unacceptable toxicity Patients experiencing disease progression intolerance to imatinib mesylate lack of major cytogenetic response at 12 weeks or 30 absolute reduction in Philadelphia chromosome-positive metaphases at 12 weeks cross over to arm I after a 1-week washout period After crossover patients receive oral BMS-354825 twice daily in the absence of further disease progression or unacceptable toxicity
Quality of life is assessed at baseline at day 29 every 4 weeks for 24 weeks every 12 weeks for the remainder of study treatment and then at the completion of study treatment
After the completion of study treatment patients are followed for at least 30 days
PROJECTED ACCRUAL A minimum of 150 patients 100 in arm I and 50 in arm II will be accrued for this study within 6-12 months
Primary
Determine the 12-week major cytogenetic response MCyR rate in patients with imatinib mesylate-resistant Philadelphia chromosome-positive chronic phase chronic myelogenous leukemia treated with BMS-354825 vs imatinib mesylate
Secondary
Determine the MCyR rate prior to crossover in patients treated with these drugs
Determine the durability of MCyR and time to MCyR prior to crossover in patients treated with these drugs
Determine the complete hematologic response CHR rate prior to crossover in patients treated with these drugs
Determine the durability of CHR and time to CHR prior to crossover in patients treated with these drugs
Determine the major molecular response rate prior to crossover as determined by BCR-ABL transcripts in blood during treatment using quantitative reverse transcriptase polymerase chain reaction in patients treated with these drugs
Determine post-crossover efficacy endpoints in patients treated with these drugs who crossover
Assess health-related quality of life prior to crossover in patients treated with these drugs
Determine the safety and tolerability of BMS-354825 in these patients
Determine the pharmacokinetics of BMS-354825 in these patients
OUTLINE This is an open-label multicenter randomized crossover study Patients are stratified according to study site and cytogenetic response to prior imatinib mesylate yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral BMS-354825 twice daily in the absence of disease progression or unacceptable toxicity Patients experiencing disease progression or persistent intolerance to BMS-354825 cross over to arm II after a 2-day washout period After crossover patients receive oral imatinib mesylate twice daily in the absence of further disease progression or unacceptable toxicity
Arm II Patients receive oral imatinib mesylate twice daily in the absence of disease progression or unacceptable toxicity Patients experiencing disease progression intolerance to imatinib mesylate lack of major cytogenetic response at 12 weeks or 30 absolute reduction in Philadelphia chromosome-positive metaphases at 12 weeks cross over to arm I after a 1-week washout period After crossover patients receive oral BMS-354825 twice daily in the absence of further disease progression or unacceptable toxicity
Quality of life is assessed at baseline at day 29 every 4 weeks for 24 weeks every 12 weeks for the remainder of study treatment and then at the completion of study treatment
After the completion of study treatment patients are followed for at least 30 days
PROJECTED ACCRUAL A minimum of 150 patients 100 in arm I and 50 in arm II will be accrued for this study within 6-12 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EUDRACT-2004-004450-96 | None | None | None |
| UCLA-0501047-01 | None | None | None |
| BMS-CA180017 | None | None | None |