Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-31 @ 3:14 PM
Study NCT ID:
NCT03179956
Status:
TERMINATED
Last Update Posted:
2019-02-25
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Ribociclib on Head and Neck Squamous Cell Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Study Overview
Official Title:
Biomarker Window of Opportunity Study to Evaluate the Impact of Ribociclib on Head and Neck Squamous Cell Cancer
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A window of opportunity study which would allow brief treatment of HPV negative SCCHN with a CDK4/6 inhibitor, in the pre-operative setting, with biomarker analyses of pre and post treatment tissue. Given that the standard treatment for this population is surgical resection, this would not impact or alter standard therapy for this population. The goal will be to learn more about the alterations in pRB1 levels, as well as other signaling markers, in order to be able to eventually plan a biomarker driven treatment study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: