Ignite Creation Date:
2024-05-06 @ 2:47 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02129647
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2014-04-29
Brief Title:
Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase II Study of Axitinib in Patients With Neurofibromatosis Type 2 and Progressive Vestibular Schwannomas
Status:
COMPLETED
Status Verified Date:
2021-11
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:
The purpose of this study is to determine if the study drug AXITINIB has any effect on tumors found in patients with Neurofibromatosis Type 2 NF2
Detailed Description:
NF2 is a condition that mainly affects the skin and nervous system It causes non-cancerous tumors to grow on the nerves around a persons body Some signs of NF2 include a gradual loss of hearing and tumors growing on the skin the brain and the spinal cord which can lead to complications
AXITINIB is an oral drug taken by mouth that is approved by the United States Food and Drug Administration FDA for the treatment of other types of tumors However in this research study AXITINIB is considered investigational because it is not approved by the FDA for treatment of NF2 Much is known regarding how well it is tolerated handled but investigators do not know if it is effective in treating NF2
This research study will test whether AXITINIB may shrink tumors commonly found in patients with NF2 or stop them from growing This will help to decide if AXITINIB should be used to treat NF2 patients in the future AXITINIB is a drug that has been used to treat various forms of cancer It has not been studied for the treatment of tumors in NF2 patients Investigators have selected AXITINIB for this clinical trial in patients with NF2 and NF2-related tumors because a very similar drug bevacizumab can shrink Vestibular Schwannomas VS in some NF2 patients
Pfizer Inc the manufacturer of the study drug AXITINIB will provide the AXITINIB being used in this study
Primary Objective To estimate the objective volumetric response rates to axitinib in adult NF2 patients with VS
Secondary Objectives To assess the toxicity of axitinib given daily in patients with NF2 and to examine the association of objective measures of response on MRI ie volumetric tumor analysis with clinical measures of response ie audiogram as well as quality of life assessments NFTI-QOL In addition response in non-VS tumors such as other schwannomas and meningiomas may be explored
AXITINIB is an oral drug taken by mouth that is approved by the United States Food and Drug Administration FDA for the treatment of other types of tumors However in this research study AXITINIB is considered investigational because it is not approved by the FDA for treatment of NF2 Much is known regarding how well it is tolerated handled but investigators do not know if it is effective in treating NF2
This research study will test whether AXITINIB may shrink tumors commonly found in patients with NF2 or stop them from growing This will help to decide if AXITINIB should be used to treat NF2 patients in the future AXITINIB is a drug that has been used to treat various forms of cancer It has not been studied for the treatment of tumors in NF2 patients Investigators have selected AXITINIB for this clinical trial in patients with NF2 and NF2-related tumors because a very similar drug bevacizumab can shrink Vestibular Schwannomas VS in some NF2 patients
Pfizer Inc the manufacturer of the study drug AXITINIB will provide the AXITINIB being used in this study
Primary Objective To estimate the objective volumetric response rates to axitinib in adult NF2 patients with VS
Secondary Objectives To assess the toxicity of axitinib given daily in patients with NF2 and to examine the association of objective measures of response on MRI ie volumetric tumor analysis with clinical measures of response ie audiogram as well as quality of life assessments NFTI-QOL In addition response in non-VS tumors such as other schwannomas and meningiomas may be explored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None