Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082823
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2004-05-14
Brief Title:
Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkins Lymphoma
Sponsor:
Regeneron Pharmaceuticals
Organization:
Regeneron Pharmaceuticals
Study Overview
Official Title:
An Open-Label Long-Term Safety and Tolerability Study of VEGF Trap Administered Intravenously in Patients With Advanced 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 Intravenous VEGF Trap may stop the growth of solid tumors or non-Hodgkins lymphoma by stopping blood flow to the cancer
PURPOSE This phase I trial is studying the side effects of VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkins lymphoma
PURPOSE This phase I trial is studying the side effects of VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkins lymphoma
Secondary
Determine the steady-state pharmacokinetics of this drug in these patients
Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients
Determine whether antibodies to this drug develop in these patients
Determine preliminarily the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients
OUTLINE This is an open-label multicenter extension study
Patients receive VEGF Trap IV over 1 hour on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
NOTE Patients receive the same drug dose that they received in MSKCC-03137 VGFT-ST-0202
Patients are followed monthly for 3 months
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 3-6 months
Primary
Determine the safety and tolerability of intravenous VEGF Trap in patients with relapsed or refractory advanced solid tumors or non-Hodgkins lymphoma
Secondary
Determine the steady-state pharmacokinetics of this drug in these patients
Determine the ability of this drug to bind circulating vascular endothelial growth factor in these patients
Determine whether antibodies to this drug develop in these patients
Determine preliminarily the ability of repeated doses of this drug to alter tumor growth and vascular permeability in these patients
OUTLINE This is an open-label multicenter extension study
Patients receive VEGF Trap IV over 1 hour on day 1 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
NOTE Patients receive the same drug dose that they received in MSKCC-03137 VGFT-ST-0202
Patients are followed monthly for 3 months
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 3-6 months
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 |
|---|---|---|---|
| CDR0000360846 | REGISTRY | PDQ Physician Data Query | None |
| MSKCC-03138 | None | None | None |