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Clinical Trials/EUCTR2008-007097-38-FR
EUCTR2008-007097-38-FR
Active, not recruiting
Phase 1

A randomized, open-label Phase II study of BIBW 2992 versus cetuximab (Erbitux®) in patients with metastatic or recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) after failure of platinum-containing therapy with a cross-over period for progressing patients.

Boehringer-Ingelheim France0 sites146 target enrollmentMarch 19, 2009
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ConditionsMetastatic or recurrent Head and Neck Squamous Cell Carcinoma
DrugsErbitux®

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Metastatic or recurrent Head and Neck Squamous Cell Carcinoma
Sponsor
Boehringer-Ingelheim France
Enrollment
146
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 19, 2009
End Date
July 26, 2013
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Metastatic (stage IV) or recurrent HNSCC
  • •Histologically or cytologically confirmed diagnosis of squamous cell carcinomas of the head and the neck.
  • •Patients must have documented progressive disease following receipt of prior platinum\-based therapy.
  • •Patients must have measurable disease as defined by RECIST criteria.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.
  • •Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting
  • •More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.
  • •Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
  • •Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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