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Neoadjuvant Afatinib Window Study in Squamous Cell Carcinoma of the Head and Neck

NCT01538381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-07-09

No results posted yet for this study

Summary

The general objectives are to evaluate the pre-operative activity and the safety of afatinib in head and neck cancer and to explore the different downstream molecular pathways to identify tumor response and resistance mechanisms. The results from this study can be used to conduct a larger trial that would allow us to confirm or validate the hypotheses generated.

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

Afatinib

Afatinib for 2 weeks at a dose of 40 mg/day

OTHER

Observation

Observation

Sponsors & Collaborators

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Jean-Pascal Machiels, MD · European Organisation for Research and Treatment of Cancer - EORTC

  • Lisa Licitra, MD · European Organisation for Research and Treatment of Cancer - EORTC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Belgium
  • Italy

Study Locations

More Related Trials

Entities

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 NCT01538381 on ClinicalTrials.gov