BIBW 2992 (Afatinib) in Head & Neck Cancer

Completed · Phase 2

Conditions studied: Head and Neck Neoplasms, Carcinoma, Squamous Cell

In brief

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.

Key facts

Study ID: NCT00514943
Run by: Boehringer Ingelheim
People needed: 124
Starts: 2007-08-01
Expected to finish: 2013-07-01
Last updated by the study team: 2016-07-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Patients must be eighteen (18) years of age or older. 10. Willingness and ability to give written informed consent consistent with ICH-GCP guidelines.

You may not qualify if…

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 (treatment with cetuximab (Erbitux®) or other EGFR inhibitor during radiotherapy or chemoradiotherapy is permissible).
More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.
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
eliminated per Amendment #1
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.
Patients with history of decompensated heart failure.
Cardiac left ventricular function with resting ejection fraction <50% or less than the institutional lower limit of normal by MUGA or echocardiogram.
Active infectious disease.
Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol.
Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.
Patients unable to comply with the protocol.
Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal cerebral MRI scan at screening and be at least three months post-radiation or surgery.
Absolute neutrophile count (ANC) less than 1000/mm3.
Platelet count less than 75,000/mm3.
Bilirubin greater than 1.5 mg/dl/ Higher bilirubin values are acceptable for patients with known Gilbert's disease, approval by the PI and sponsor necessary.
Asparate amino transferase (AST) or alanine amino transferase (ALT) greater than 3 times the upper limit of normal.
Serum creatinine greater than 1.5 X upper limit of normal for the institution.
Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
Pregnancy or breast-feeding.
Patients with known pre-existing interstitial lung disease.

Where it is running

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
1200.28.0006 Boehringer Ingelheim Investigational Site — Omaha, Nebraska, United States
1200.28.0008 Boehringer Ingelheim Investigational Site — New Hyde Park, New York, United States
1200.28.0017 Boehringer Ingelheim Investigational Site — Chapel Hill, North Carolina, United States
1200.28.0004 Boehringer Ingelheim Investigational Site — Winston-Salem, North Carolina, United States
1200.28.0013 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
1200.28.0007 Boehringer Ingelheim Investigational Site — Houston, Texas, United States
1200.28.0009 Boehringer Ingelheim Investigational Site — Madison, Wisconsin, United States
1200.28.0020 Boehringer Ingelheim Investigational Site — Milwaukee, Wisconsin, United States
1200.28.0030 Boehringer Ingelheim Investigational Site — Brussels, Belgium
1200.28.0031 Boehringer Ingelheim Investigational Site — Ghent, Belgium
1200.28.0032 Boehringer Ingelheim Investigational Site — Leuven, Belgium
1200.28.0062A Boehringer Ingelheim Investigational Site — Alès, France
1200.28.0062B Boehringer Ingelheim Investigational Site — Alès, France
1200.28.0059A Boehringer Ingelheim Investigational Site — Avignon, France
1200.28.0052A Boehringer Ingelheim Investigational Site — Lille, France

Full record on ClinicalTrials.gov

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