Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085566
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2004-06-10
Brief Title:
Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase III Trial to Assess the Tolerability of RAD 001 With Gefitinib in Patients With Glioblastoma Multiforme and Prostate Cancer and Efficacy in Patients With Castrate Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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 Everolimus may stop the growth of tumor cells by stopping blood flow to the tumor Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Combining everolimus with gefitinib may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of everolimus when given together with gefitinib and to see how well they work in treating patients with progressive glioblastoma multiforme or progressive metastatic prostate cancer closed to accrual 101906
PURPOSE This phase III trial is studying the side effects and best dose of everolimus when given together with gefitinib and to see how well they work in treating patients with progressive glioblastoma multiforme or progressive metastatic prostate cancer closed to accrual 101906
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of everolimus when given in combination with gefitinib in patients with progressive glioblastoma multiforme or progressive castrate metastatic prostate cancer -closed to accrual as of 10192006 Phase I
Determine the safety and efficacy of this regimen in patients with progressive glioblastoma multiforme or progressive castrate metastatic prostate cancer - closed to accrual as of 10192006 Phase II
Secondary
Determine whether a pharmacokinetic interaction exists between everolimus and gefitinib in patients treated with this regimen
Determine the association between clinical outcomes and markers that may predict sensitivity of a tumor in patients treated with this regimen
Determine the pharmacodynamic effects of this regimen on post-therapy tumor specimens and peripheral blood mononuclear cells from these patients
OUTLINE This is a phase I open-label non-randomized dose-escalation study of everolimus followed by a phase II study
Phase I Patients receive oral everolimus on day 1 and oral gefitinib once daily on days 8-21 Beginning on day 22 patients receive oral everolimus once weekly and oral gefitinib once daily Treatment with the combination continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 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 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II prostate cancer patients only closed to accrual as of 10192006 Patients receive oral everolimus at the MTD determined in phase I once weekly and oral gefitinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
Primary
Determine the maximum tolerated dose of everolimus when given in combination with gefitinib in patients with progressive glioblastoma multiforme or progressive castrate metastatic prostate cancer -closed to accrual as of 10192006 Phase I
Determine the safety and efficacy of this regimen in patients with progressive glioblastoma multiforme or progressive castrate metastatic prostate cancer - closed to accrual as of 10192006 Phase II
Secondary
Determine whether a pharmacokinetic interaction exists between everolimus and gefitinib in patients treated with this regimen
Determine the association between clinical outcomes and markers that may predict sensitivity of a tumor in patients treated with this regimen
Determine the pharmacodynamic effects of this regimen on post-therapy tumor specimens and peripheral blood mononuclear cells from these patients
OUTLINE This is a phase I open-label non-randomized dose-escalation study of everolimus followed by a phase II study
Phase I Patients receive oral everolimus on day 1 and oral gefitinib once daily on days 8-21 Beginning on day 22 patients receive oral everolimus once weekly and oral gefitinib once daily Treatment with the combination continues in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 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 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II prostate cancer patients only closed to accrual as of 10192006 Patients receive oral everolimus at the MTD determined in phase I once weekly and oral gefitinib once daily Treatment continues in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| MSKCC-04010 | None | None | None |