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Cabozantinib in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer

NCT03667482 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-07-23

No results posted yet for this study

Summary

The purpose of this study is to test the safety of cabozantinib, at different doses, in combination with cetuximab to find out what effects, if any, this combined treatment has on people with HNSCC.

Conditions

  • Head and Neck Squamous Cell Cancer
  • Recurrent Head and Neck Squamous Cell Cancer
  • Metastatic Head and Neck Squamous Cell Cancer

Interventions

DRUG

Cabozantinib

Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.

DRUG

Cetuximab

Cetuximab will be administered at 500 mg/m\^2 intravenously every other week on Days 1 and 15 of each cycle, with a window of up to 3 days before the scheduled date. In an effort to prevent a hypersensitivity reaction, it is recommended that all patients pre-medications, hydration, and anti-emetics will be given according to institutional guidelines and/or per treating physician discretion.

Sponsors & Collaborators

Principal Investigators

  • Loren Michel, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2024-07-17
Completion
2024-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03667482 on ClinicalTrials.gov