Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036946
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2002-05-13
Brief Title:
VEGF Trap in Treating Patients With Relapsed or Refractory Solid Tumors or Non-Hodgkins Lymphoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
An Open-Label Sequential Cohort Dose-Escalation Safety Tolerability And Pharmacokinetic Study Of VEGF Trap In Patients With Incurable Relapsed Or Refractory Solid Tumors Or Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-06
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 VEGF Trap may stop the growth of solid tumors or non-Hodgkins lymphoma by stopping blood flow to the cancer
PURPOSE Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed or refractory solid tumors or non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of VEGF Trap in patients who have relapsed or refractory solid tumors or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkins lymphoma
Determine the maximum tolerated dose of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Evaluate the ability of this drug to bind and inactivate circulating vascular endothelial growth factor VEGF in these patients
Determine the dosing regimen that is optimal for neutralization of circulating VEGF in these patients
Determine whether antibodies to this drug develop in these patients
Assess preliminarily the ability of this drug to alter tumor vascular permeability and tumor growth in these patients
OUTLINE This is a dose-escalation study
Patients receive VEGF Trap subcutaneously once daily on days 1 29 36 43 50 57 and 64 in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of VEGF Trap 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 Once the MTD is determined 5 additional patients are treated at the MTD
Patients are followed at 1 and 4 weeks
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
Determine the safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkins lymphoma
Determine the maximum tolerated dose of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
Evaluate the ability of this drug to bind and inactivate circulating vascular endothelial growth factor VEGF in these patients
Determine the dosing regimen that is optimal for neutralization of circulating VEGF in these patients
Determine whether antibodies to this drug develop in these patients
Assess preliminarily the ability of this drug to alter tumor vascular permeability and tumor growth in these patients
OUTLINE This is a dose-escalation study
Patients receive VEGF Trap subcutaneously once daily on days 1 29 36 43 50 57 and 64 in the absence of disease progression or unacceptable toxicity
Cohorts of 1-6 patients receive escalating doses of VEGF Trap 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 Once the MTD is determined 5 additional patients are treated at the MTD
Patients are followed at 1 and 4 weeks
PROJECTED ACCRUAL A maximum of 30 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 |
|---|---|---|---|
| NCI-G02-2065 | Registry Identifier | PDQ Physician Data Query | None |
| MSKCC-01131 | None | None | None |
| CDR0000069343 | REGISTRY | None | None |