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Study of LEE011plus Cetuximab in Patients With a Cancer of the Head and Neck

NCT02429089 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-01-09

No results posted yet for this study

Summary

In this trial, the investigators would like to investigate the activity of LEE011 associated with cetuximab (standard of care for the SCCHN patients at this stade of the disease).

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

LEE011

The first 12 patients will receive cetuximab associated with LEE011 at doses of 400 mg and 600 mg daily to determine the DLTs and safety. In the expansion part, besides safety, objective response rate, progression-free survival and overall survival will be calculated with the inclusion of 14 patients.

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Institut Roi Albert II Cliniques universitaires Saint-Luc · Institut Roi Albert II, Cliniques universitaires Saint-Luc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-09-01
Completion
2018-09-01

Countries

  • Belgium

Study Locations

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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 NCT02429089 on ClinicalTrials.gov