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Impact of Ribociclib on Head and Neck Squamous Cell Cancer

NCT03179956 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-02-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Jessica Bauman, MD · Fox Chase Cancer Center

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-02
Primary Completion
2018-11-12
Completion
2019-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03179956 on ClinicalTrials.gov