Impact of Ribociclib on Head and Neck Squamous Cell Cancer

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT03179956
Phase
EARLY_PHASE1
Status
Terminated

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 2, 2018
Status verified
Feb 2019
Primary completion
Nov 12, 2018
Completion
Jan 10, 2019

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Ribociclib

Primary Outcome Measure

Treatment with a CDK4/6 inhibitor, Ribociclib, decreases pRB1 levels in patients with SCCHN of the oral cavity, oropharynx and larynx. [ Time Frame: 1-2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

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By research site
Fox Chase Cancer Center· Philadelphia, PA

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