PER-146-08已完成未知
An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Genmab A/S,
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 0（—）
入选标准
- •Men and women with ages of> 18 years (> 19 years in countries where patients are requested this age for their participation in a clinical study).
- •Histologically or cytologically confirmed diagnosis, at an initial or recurrence stage, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy.
- •Failure in at least one standard chemotherapy scheme based on platinum.
- •Measurable disease defined as one or more target lesions according to RECIST.
- •WHO performance status <2.
- •After receiving verbal and written information about the study, the patient must provide signed informed consent before any activity related to the study is carried out.
排除标准
- •Three or more previous chemotherapy regimens, other than platinum-based chemotherapy.
- •Previous treatment with EGFr antibodies and / or small molecule anti-EGFr inhibitors
- •Have received the following treatments within 4 weeks prior to the administration of the study medication (visit 2): Cytotoxic or cytostatic chemotherapy against cancer, Total tumor removal
- •Previous or current malignancy, other than CCECC, except for: Stage IB cervical carcinoma or less, Non-invasive squamous cell carcinoma of the skin or basal cells, Malignant melanoma with a complete response lasting> 10 years, Other Cancer diagnoses with a complete response lasting> 5 years, Stage 1 or 2 prostate cancer with prostate specific antigen (PSA) in the normal range for> 2 years after treatment.
- •Diseases chronic or ongoing infections such as, among others: chronic kidney infection, chronic chest infection with bronchiestasls, sinusitis, and tuberculosis. Secondary infections in tumor lesions are excluded.
- •Known brain metastases or leptomeningeal disease.
- •Significant clinical heart disease that includes: unstable angina, acute myocardial infarction within six months of Visit 1, Congestive heart failure and arrhythmia requiring therapy, with the exception of extrasystoles or minor conduction abnormalities.
- •Significant, concomitant, uncontrolled medical condition, including, but not limited to: kidney, liver, hematologic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease that, according to the investigator´s evaluation, interferes with the effect of the study medication.
- •Expected survival <3 months.
- •HIV positive known.
- •Hepatitis B and / or C known.
- •Values of laboratory tests during selection: Neutrophils <1.5 x 10 6 / L, Platelets <75 x 10 6 / L, ALAT> 2.5 times the upper limit of normal value (unless the existence of liver metastases is known ), ALP> 2.5 times the upper limit of the normal value (unless the existence of bone metastases is known), Bllirubin> 1.5 times the upper limit of the normal value, Creatinine Clearance calculated <50 mL / min,
- •Current participation in any other clinical interventionist study.
- •Patients who are known or suspected would not be able to comply with this study protocol.
- •Women who are breastfeeding or women with a positive pregnancy test at Visit 1.
- •Women of childbearing age who are not willing to use a suitable contraceptive such as hormonal birth control, an intrauterine device or a double barrier method, during the study and 12 months after the last dose of Zalutumumab.
研究者
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