Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474929
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2007-05-16
Brief Title:
Sorafenib and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
A Phase III Study of the Raf KinaseVEGFR Inhibitor Sorafenib in Combination With the mTOR Inhibitor RAD001 Everolimus in Patients With Relapsed Non-Hodgkin Lymphoma Hodgkin Lymphoma or Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2019-02
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 Sorafenib and everolimus may stop the growth of cancer cells by blocking blood flow to the cancer and by blocking some of the enzymes needed for cell growth
PURPOSE This phase III trial is studying the side effects and best dose of sorafenib and everolimus and to see how well they work in treating patients with relapsed or refractory non-Hodgkins lymphoma Hodgkins lymphoma or multiple myeloma
PURPOSE This phase III trial is studying the side effects and best dose of sorafenib and everolimus and to see how well they work in treating patients with relapsed or refractory non-Hodgkins lymphoma Hodgkins lymphoma or multiple myeloma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of sorafenib tosylate and everolimus in patients with relapsed or refractory non-Hodgkins lymphoma Hodgkins lymphoma or multiple myeloma
Determine the toxicity of this regimen in these patients
Evaluate the therapeutic activity of this regimen in these patients
Evaluate the pharmacokinetic interaction of this regimen
Correlate clinical toxicity andor tumor response or activity effects with pharmacologic pharmacokineticpharmacodynamic parameters andor biologic correlative laboratory results
OUTLINE This is a multicenter dose-escalation phase I study followed by a phase II study
Phase I closed to accrual as of 2102009 Patients receive oral sorafenib tosylate and oral everolimus on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of sorafenib tosylate and everolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 out of at most 6 patients experience a Dose Limiting Toxicity DLT
Phase II Patients receive oral sorafenib tosylate twice daily and oral everolimus once daily at the MTD determined in phase I Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Blood and bone marrow are collected periodically during the study and analyzed by flow cytometry immunohistochemistry and enzyme-linked immunosorbent assay Patients enrolled in phase I also undergo blood sample collection on days 8 and 15 during course 1 and on day 1 of each subsequent course for pharmacokinetic studies
After completion of study treatment patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 103 patients will be accrued for this study
Determine the maximum tolerated dose MTD of sorafenib tosylate and everolimus in patients with relapsed or refractory non-Hodgkins lymphoma Hodgkins lymphoma or multiple myeloma
Determine the toxicity of this regimen in these patients
Evaluate the therapeutic activity of this regimen in these patients
Evaluate the pharmacokinetic interaction of this regimen
Correlate clinical toxicity andor tumor response or activity effects with pharmacologic pharmacokineticpharmacodynamic parameters andor biologic correlative laboratory results
OUTLINE This is a multicenter dose-escalation phase I study followed by a phase II study
Phase I closed to accrual as of 2102009 Patients receive oral sorafenib tosylate and oral everolimus on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of sorafenib tosylate and everolimus until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 out of at most 6 patients experience a Dose Limiting Toxicity DLT
Phase II Patients receive oral sorafenib tosylate twice daily and oral everolimus once daily at the MTD determined in phase I Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Blood and bone marrow are collected periodically during the study and analyzed by flow cytometry immunohistochemistry and enzyme-linked immunosorbent assay Patients enrolled in phase I also undergo blood sample collection on days 8 and 15 during course 1 and on day 1 of each subsequent course for pharmacokinetic studies
After completion of study treatment patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 103 patients will be accrued for this study
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 |
|---|---|---|---|
| LS0689 | OTHER | Mayo Clinic Cancer Center ID | None |
| 07-000710 | OTHER | None | None |