Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT01360827
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
* Recurrent and/or metastatic SCCHN, not suitable for local therapy.
* At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).
* Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.
Exclusion Criteria:
* Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.
* Nasopharyngeal carcinoma.
* Medical history of diagnosed interstitial lung disease.
* Known hypersensitivity against any of the components of the trial treatment.
* Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).
* Relevant cardiovascular co-morbidities.
* Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent.
* Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01360827
Study Brief:
Protocol Section:
NCT01360827