Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093639
Status:
COMPLETED
Last Update Posted:
2013-05-01
First Post:
2004-10-06
Brief Title:
Everolimus and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission After Previous Imatinib Mesylate
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase I-II Study of RAD001 in Combination With Imatinib GlivecGleevec in Patients With Chronic Myelogenous Leukemia CML in Chronic Phase Who Are Not In Complete Cytogenetic Response to Imatinib-Alone at Study Entry
Status:
COMPLETED
Status Verified Date:
2013-04
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:
RATIONALE Drugs used in chemotherapy such as everolimus work in different ways to stop cancer cells from dividing so they stop growing or die Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for their growth Combining everolimus with imatinib mesylate may be effective in killing cancer cells that have become resistant to imatinib mesylate
PURPOSE This phase III trial is studying the side effects and best dose of everolimus when given together with imatinib mesylate and to see how well they work in treating patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after previous imatinib mesylate
PURPOSE This phase III trial is studying the side effects and best dose of everolimus when given together with imatinib mesylate and to see how well they work in treating patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after previous imatinib mesylate
Detailed Description:
OBJECTIVES
Primary
Determine the safety tolerability and biological activity of everolimus when combined with imatinib mesylate in patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after prior imatinib mesylate Phase I
Determine preliminarily the clinical efficacy of this regimen in terms of 3-month improvement by at least one cytogenetic category and the duration of cytogenetic improvements in these patients Phase II
Secondary
Determine the 6-month rate of cytogenetic improvements in patients treated with this regimen
Determine the rate of confirmed cytogenetic improvements in patients treated with this regimen
Determine the rate and duration of major cytogenetic response in patients treated with this regimen
Determine the rate and kinetics of molecular response in patients treated with this regimen
Correlate genetic variation in drug metabolism genes leukemia genes and drug target genes with response in patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Determine whether the mTOR pathway activity as determined by molecular pathologic examination before and during treatment with this regimen is predictive of response in these patients
OUTLINE This is a phase I non-randomized open-label multicenter dose-escalation study of everolimus followed by a phase II study Patients are stratified according to baseline cytogenetic status Philadelphia chromosome-positive cells in bone marrow 0 and 95 vs 95
Phase I Patients receive oral everolimus once daily or once weekly and oral imatinib mesylate once daily beginning on day 1 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 4-6 patients receive escalating doses of everolimus 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
Phase II Patients receive everolimus and imatinib mesylate as in phase I at the MTD
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 4-98 patients 4-34 for phase I and up to 64 for phase II 34 patients with 0 and 95 Philadelphia chromosome Ph-positive cells and 30 patients with 95 Ph-positive cells will be accrued for this study
Primary
Determine the safety tolerability and biological activity of everolimus when combined with imatinib mesylate in patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after prior imatinib mesylate Phase I
Determine preliminarily the clinical efficacy of this regimen in terms of 3-month improvement by at least one cytogenetic category and the duration of cytogenetic improvements in these patients Phase II
Secondary
Determine the 6-month rate of cytogenetic improvements in patients treated with this regimen
Determine the rate of confirmed cytogenetic improvements in patients treated with this regimen
Determine the rate and duration of major cytogenetic response in patients treated with this regimen
Determine the rate and kinetics of molecular response in patients treated with this regimen
Correlate genetic variation in drug metabolism genes leukemia genes and drug target genes with response in patients treated with this regimen
Determine the pharmacokinetics of this regimen in these patients
Determine whether the mTOR pathway activity as determined by molecular pathologic examination before and during treatment with this regimen is predictive of response in these patients
OUTLINE This is a phase I non-randomized open-label multicenter dose-escalation study of everolimus followed by a phase II study Patients are stratified according to baseline cytogenetic status Philadelphia chromosome-positive cells in bone marrow 0 and 95 vs 95
Phase I Patients receive oral everolimus once daily or once weekly and oral imatinib mesylate once daily beginning on day 1 Treatment continues in the absence of disease progression or unacceptable toxicity
Cohorts of 4-6 patients receive escalating doses of everolimus 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
Phase II Patients receive everolimus and imatinib mesylate as in phase I at the MTD
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 4-98 patients 4-34 for phase I and up to 64 for phase II 34 patients with 0 and 95 Philadelphia chromosome Ph-positive cells and 30 patients with 95 Ph-positive cells will be accrued for this study
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 |
|---|---|---|---|
| NCI-2010-00894 | REGISTRY | CTRP Clinical Trials Reporting System | None |
| RPCI-PH-24204 | None | None | None |
| CDR0000389252 | REGISTRY | None | None |