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BIBW 2992 (Afatinib) in Head & Neck Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

BIBW 2992 (Afatinib) in Head & Neck Cancer

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

NCT00514943•Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Metastatic (stage IVc) or recurrent HNSCC 2. Histologically or cytologically confirmed diagnosis of squamous cell of the head and neck. Patients with well-differentiated (keratinizing) nasopharyngeal carcinomas and patients with squamous cell carcinomas metastatic to the neck from an unknown head and neck primary are eligible. 3. Patients must have documented progressive disease (PD) following receipt of prior platinum-based therapy (either as neoadjuvant, adjuvant, concomitant with radiotherapy, or for recurrent/ metastatic disease). 4. Patients must have measurable disease as defined by RECIST criteria. 5. Patients must have recovered from any therapy-related toxicities from previous chemo-, immuno-, or radiotherapies to CTC smaller or equal to Grade 1. 6. Patients must have recovered from previous surgery. 7. Life expectancy of at least three (3) months. 8. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score 0 or 1.
•9\. Patients must be eighteen (18) years of age or older. 10. Willingness and ability to give written informed consent consistent with ICH-GCP guidelines.

Exclusion Criteria

•1. Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.
•2. Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting (treatment with cetuximab (Erbitux®) or other EGFR inhibitor during radiotherapy or chemoradiotherapy is permissible).
•3. More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.
•4. Treatment with other investigational drugs, other anti-cancer-therapy (e.g., chemotherapy, immunotherapy, radiotherapy), concomitantly with therapy on this study and/or during the last four weeks, prior to the first treatment with the trial drug
•5. eliminated per Amendment #1
•6. Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.
•7. Patients with history of decompensated heart failure.
•8. Cardiac left ventricular function with resting ejection fraction \<50% or less than the institutional lower limit of normal by MUGA or echocardiogram.
•9. Active infectious disease.
•10. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
+12 more criteria

Locations (36)

1200.28.0010 Boehringer Ingelheim Investigational Site

Stanford, California, United States

1200.28.0001 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

1200.28.0005 Boehringer Ingelheim Investigational Site

Chicago, Illinois, United States

1200.28.0011 Boehringer Ingelheim Investigational Site

Harvey, Illinois, United States

1200.28.0022 Boehringer Ingelheim Investigational Site

Indianapolis, Indiana, United States

1200.28.0024 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

1200.28.0012 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

1200.28.0021 Boehringer Ingelheim Investigational Site

Saint Joseph, Michigan, United States

1200.28.0016 Boehringer Ingelheim Investigational Site

Rochester, Minnesota, United States

1200.28.0002 Boehringer Ingelheim Investigational Site

Jackson, Mississippi, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

March 1, 2010

Completion Date

July 1, 2013

Last Updated

July 26, 2016

Enrollment

124

ACTUAL participants

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

BIBW 2992

DRUG

Cetuximab

DRUG

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT04099290

Head and Neck NeoplasmCarcinoma, Squamous Cell

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RECRUITINGPHASE3

Head and Neck Cancer Study Project in the Geriatric Population

NCT06998069

Head and Neck Neoplasms

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RECRUITINGPHASE1

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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BIBW 2992 (Afatinib) in Head & Neck Cancer

Inclusion Criteria

Exclusion Criteria

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

Head and Neck Cancer Study Project in the Geriatric Population

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC

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