Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045266
Status:
COMPLETED
Last Update Posted:
2016-06-03
First Post:
2002-09-06
Brief Title:
VEGF Trap in Treating Patients With 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 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 treating patients who have relapsed or refractory solid tumors or non-Hodgkins lymphoma
PURPOSE Phase I trial to study the effectiveness of VEGF Trap in treating patients who have relapsed or refractory solid tumors or non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkins lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131
Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients
Determine the steady state concentration of VEGF Trap over time in these patients
Determine whether patients develop antibodies to this therapy during extended exposure
OUTLINE This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131
Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity Patients receive treatment at the same dose level as on protocol MSKCC-01131
Patients are followed at approximately 30 days
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
Determine the long-term safety and tolerability of VEGF Trap in patients with incurable relapsed or refractory solid tumors or non-Hodgkins lymphoma with stable or responding disease after receiving treatment on protocol MSKCC-01131
Determine the biological effect of this therapy on suppressing tumor growth or progression in these patients
Determine the steady state concentration of VEGF Trap over time in these patients
Determine whether patients develop antibodies to this therapy during extended exposure
OUTLINE This is an extension study for patients who showed evidence of stable disease or complete or partial remission after completing treatment on protocol MSKCC-01131
Patients continue to receive VEGF Trap subcutaneously once weekly for up to an additional 6 months in the absence of unacceptable toxicity Patients receive treatment at the same dose level as on protocol MSKCC-01131
Patients are followed at approximately 30 days
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G-02-2101 | Registry Identifier | PDQ Physician Data Query | None |
| MSKCC-02020 | None | None | None |
| CDR0000256462 | REGISTRY | None | None |