Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00303732
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2006-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vatalanib and Everolimus in Treating Patients With Advanced Solid Tumors
Sponsor:
Daniel George, MD
Organization:
Study Overview
Official Title:
PTK787/ZK222584 and RAD001 for Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-03
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:
PTK/RAD
Brief Summary:
RATIONALE: Vatalanib and everolimus may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of vatalanib and everolimus and to see how well they work in treating patients with advanced solid tumors.
Detailed Description:
OBJECTIVES:
Primary
* Determine the maximum tolerated dose (MTD) of vatalanib and everolimus in patients with advanced solid tumors.
* Determine the safety and tolerability of vatalanib and everolimus in patients with advanced solid tumors.
* Evaluate the safety and tolerability of vatalanib and everolimus at the MTD in patients with metastatic renal cell carcinoma (RCC).
Secondary
* Describe the non dose-limiting toxic effects associated with vatalanib and everolimus.
* Describe the pharmacokinetics of vatalanib and everolimus in patients with advanced solid tumors.
* Determine the functional extent of mTOR inhibition by changes in the phosphorylation status of S6K protein in peripheral blood mononuclear cells in patients treated with vatalanib and everolimus.
* Describe any clinical responses seen in patients with metastatic RCC in a dose-expansion cohort treated at the MTD.
* Observe overall survival of RCC patients treated with vatalanib and everolimus.
* Determine the time to progression of patients with RCC treated with vatalanib and everolimus.
OUTLINE: This is a phase I dose-escalation study followed by a phase Ib study.
* Phase I (solid tumors): Patients receive oral vatalanib on days 1-28 and oral everolimus on days 15-28 during course 1 and on days 1-28 during all subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vatalanib and 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 Ib (renal cell carcinoma only): Patients receive oral vatalanib and oral everolimus at the MTD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Primary
* Determine the maximum tolerated dose (MTD) of vatalanib and everolimus in patients with advanced solid tumors.
* Determine the safety and tolerability of vatalanib and everolimus in patients with advanced solid tumors.
* Evaluate the safety and tolerability of vatalanib and everolimus at the MTD in patients with metastatic renal cell carcinoma (RCC).
Secondary
* Describe the non dose-limiting toxic effects associated with vatalanib and everolimus.
* Describe the pharmacokinetics of vatalanib and everolimus in patients with advanced solid tumors.
* Determine the functional extent of mTOR inhibition by changes in the phosphorylation status of S6K protein in peripheral blood mononuclear cells in patients treated with vatalanib and everolimus.
* Describe any clinical responses seen in patients with metastatic RCC in a dose-expansion cohort treated at the MTD.
* Observe overall survival of RCC patients treated with vatalanib and everolimus.
* Determine the time to progression of patients with RCC treated with vatalanib and everolimus.
OUTLINE: This is a phase I dose-escalation study followed by a phase Ib study.
* Phase I (solid tumors): Patients receive oral vatalanib on days 1-28 and oral everolimus on days 15-28 during course 1 and on days 1-28 during all subsequent courses. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of vatalanib and 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 Ib (renal cell carcinoma only): Patients receive oral vatalanib and oral everolimus at the MTD on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?: