NCT03179956

Impact of Ribociclib on Head and Neck Squamous Cell Cancer

Biomarker Window of Opportunity Study to Evaluate the Impact of Ribociclib on Head and Neck Squamous Cell Cancer

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DRUG	Ribociclib	Treatment with ribociclib \[600mg\] will be from Days 1-14, with surgical resection on Day 14. Labs (CBC, CMP, coagulation parameters) and an ECG will be checked once in a window defined by days 9-12.

Timeline

• Start date: 2018-04-02
• Primary completion: 2018-11-12
• Completion: 2019-01-10
• First posted: 2017-06-07
• Last updated: 2019-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study