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:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-24 @ 9:49 PM
NCT ID:
NCT00971932
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed diagnosis of SCCHN
2. Confirmed epidermal growth factor receptor (EGFR) expression in tumor tissue by immunohistochemistry (IHC)
3. Expected survival is more than 6 months
4. Presence of at least 1 bidimensionally measurable lesion either by computed tomography (CT) scan or magnetic resonance imaging (MRI)
5. Recurrent and/or metastatic SCCHN not suitable for local therapy
6. Greater than or equal to (\>=) 20 years of age
7. Karnofsky performance status (KPS) \>= 70% at trial entry
8. Neutrophils: \>= 1500 per millimeter\^3 (1,500/mm\^3); platelet count \>= 100,000/mm\^3; and hemoglobin \>= 9 gram per deciliter (g/dL)
9. Total bilirubin less than or equal to (\<=) 2 \* upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<= 3 \* ULN
10. Creatinine clearance \>60 milliliter per minute (mL/min).Calculated based on formulae such as the Cockroft-Gault formula for creatinine clearance
11. Serum calcium within normal range (If serum albumin \< 4.0 g/dL, the following adjusted serum calcium concentration should be within normality: Adjusted serum calcium concentration = actual serum calcium (milligram per deciliter \[mg/dL\]) - 0.8 \* \[actual serum albumin (g/dL) - 4\]
12. Effective contraception if risk of conception exists (applicable for both male and female subjects)
13. Signed written informed consent
14. Japanese (with Japanese citizenship)
Exclusion Criteria:
1. Nasopharyngeal carcinoma
2. Prior systemic chemotherapy, except if given as part of a multimodal treatment, which was completed more than 6 months prior to trial entry
3. Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
4. Pregnancy (absence to be confirmed by serum/urine human chorionic gonadotropin \[HCG\] test) or breastfeeding
5. Known hypersensitivity or allergic reaction against any of the components of the trial treatment including excipients
6. Uncontrolled diabetes, malignant hypertension (defined as systolic blood pressure \>= 180 millimeter of mercury \[mmHg\] and/or diastolic blood pressure \>= 130 mmHg under resting conditions) or liver failure
7. Pulmonary fibrosis, acute lung injury or interstitial pneumonia, or with previous medical history of these states
8. Active infection, (infection requiring IV antibiotics, antibacterial, antifungal, or antiviral agent), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
9. Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
10. Current other squamous cell carcinoma (SCC) or previous other malignancy (excluding skin cancer except for melanoma and carcinoma in situ of the cervix or digestive tract) within the last 5 years
11. Intake of any investigational medication within 30 days before trial entry
12. Other concomitant anticancer therapies
13. Documented or symptomatic brain or leptomeningeal metastasis
14. Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent including known drug abuse
15. Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or EGFR targeting therapy
16. Legal incapacity or limited legal capacity
17. Other protocol-defined exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT00971932
Study Brief:
Protocol Section:
NCT00971932