EUCTR2013-003695-13-IT进行中（未招募）不适用
Randomized, controlled, open label, multicenter, phase II study to evaluate the efficacy and safety of CetuGEX™ plus chemotherapy in comparison to cetuximab plus chemotherapy for the treatment of patients with stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck - RESGEX study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with histologically confirmed recurrent and/or metastatic EGFR positive SCCHN not eligible for local treatment.
- •2. Patients with measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- •3. Patients aged at least 18 years at screening.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •5. Minimum life expectancy of 3 months.
- •6. Tissue samples available for specific disease and therapy related biological assessments.
- •7. If female and of childbearing potential, is non-lactating and has negative pregnancy test results at screening and prior to randomization.
- •8. If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or using highly effective contraceptives with a failure rate < 1% according to the Note for Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95) of the European Medicines Agency (EMA). Male patients who have partners of childbearing potential have to confirm adequate use of highly effective contraceptives as well.
- •9. Willing and able to comply with the protocol.
- •10. Willing and able to provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening.
- •2. Cetuximab or other EGFR targeting agent treatment, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 6 months prior to screening.
- •3. Surgery (other than minor interventions like diagnostic biopsy or intravenous port implantation) or irradiation within 30 days before randomization.
- •4. Concomitant anti-tumor therapy or concomitant immunotherapy.
- •5. Concomitant corticosteroid treatment unless specified within the protocol.
- •6. Clinical evidence of brain metastasis or leptomeningeal involvement.
- •7. Patients with nasopharyngeal tumors.
- •8. Concomitant malignant disease, except for adequately treated tumors with high likelihood of being cured (e.g., basal cell cancer of the skin, cervical cancer or breast cancer in situ). Patients with previous malignancies but without evidence of disease for at least 5 years will be allowed to enter the study.
- •9. Patients with renal or hepatic impairment (serum creatinine and bilirubin > 1.5 fold above the upper limit of normal ranges) and transaminase > 5 fold above the upper limit of normal ranges) and patients with hematology parameters outside the normal ranges (hemoglobin < 9 g/dl, absolute neutrophil count < 1500/mm3 and platelet count < 105/mm3) at screening.
- •10. Clinically active infections = Grade 2 using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 and/or requiring intravenous antibiotics.
- •11. Known active hepatitis B or C.
- •12. Known human immunodeficiency virus (HIV) infection.
- •13. Myocardial infarction within 6 months prior to screening.
- •14. Symptomatic congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), unstable angina pectoris within 6 months prior to screening, significant cardiac arrhythmia, history of stroke or transient ischemic attack within 1 year prior to screening.
- •15. History of keratitis requiring medical interventions within the last 5 years.
- •16. Patients with any other disorder that, in the opinion of the investigator, might interfere with the conduct of the study.
- •17. Patients with an unstable condition (e.g., psychiatric disorder, a recent history of drug or alcohol abuse, interfering with study compliance, within 6 months prior to screening) or otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.
- •18. Patients institutionalized by official means or court order.
- •19. Receipt of any other investigational medicinal product within the last 30 days before randomization or any previous CetuGEX™ administration.
- •20. Prior allergic reaction to a monoclonal antibody, grade 3 IRR or any grade 4 reaction to a monoclonal antibody.
- •21. Known sensitivity to any component of the investigational medicinal product (IMP) and medication used in this study.
研究者
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