Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540963
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Tipifarnib and Naxitamab for RelapsedRefractory Neuroblastoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Trial of Tipifarnib and Naxitamab for RelapsedRefractory Neuroblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the investigational drug tipifarnib a pill taken by mouth in combination with the Food and Drug Administration FDA approved drug naxitimab administered intravenously IV a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins Naxitamab is FDA approved for pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response minor response or stable disease to prior therapy it may not be approved in the type of disease used in this study
The goals of this part of the study are
Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer
To determine the activity of study treatments chosen based on
How each subject responds to the study treatment
How long a subject lives without their disease returningprogressing
The goals of this part of the study are
Test the safety and tolerability of tipifarnib in combination with naxitimab in patients with cancer
To determine the activity of study treatments chosen based on
How each subject responds to the study treatment
How long a subject lives without their disease returningprogressing
Detailed Description:
None
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