EUCTR2006-000871-13-DE进行中（未招募）不适用
A Phase I/II, Open Label, Dose-Escalating Study Evaluating the Safety and Efficacy of the Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody EMD 72000 (Matuzumab) in Combination with the EGFR Tyrosine Kinase Inhibitor Tarceva (Erlotinib) in Subjects with Recurrent Advanced Non-Small-Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 80
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. Signed written informed consent / written informed consent for analysis of biomarker is optional and not required for participation in the main study
- •2. Male or female; Age =18 years
- •3. Histological or cytological confirmed diagnosis of advanced NSCLC
- •4. Radiographic demonstrated progression during or after treatment and have Stage IIIB/IV disease initially or at time of enrollment. The subject must have received at
- •least 1 prior therapy for NSCLC. The first line treatment must have consisted of a platinum analogue in combination with taxanes, gemcitabine, or vinorelbine
- •5. At least 1 bidimensional measurable lesion according to the modified WHO criteria
- •6. ECOG performance status of 0, 1, or 2
- •7. Adequate baseline hematologic values within 1 week prior to start of active treatment defined as follows:
- •Absolute neutrophil count (ANC) =1500 cells/µL
- •Platelet count =100,000 cells/µL
- •Hemoglobin =9.0 g/dL
- •8. Adequate organ functions within 1 week prior to start of active treatment defined as follows:
- •Serum creatinine =1.5 x upper limit of normal (ULN)
- •Total bilirubin <1.5 x ULN
- •Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =2.5 x ULN (Subjects with liver metastases should have ALT/AST <5 x ULN)
- •9. Use of an acceptable means of contraception for men and women of childbearing potential during the treatment period and continuing 2 months after the last
- •dose. Subjects of procreative potential are defined as any fertile male, or any female who has experienced menarche and who is not postmenopausal (defined as age-related amenorrhea =12 months) or who has not undergone successful surgical sterilization (hysterectomy or bilateral oophorectomy)
- •10. Toxicity related to prior therapy must have improved to =grade 1 prior to enrollment
- •11. Availability of archived tumor tissue or cytologic sample
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment with an investigational or marketed inhibitor of the EGFR pathway
- •2. Subject received systemic chemotherapy, radiotherapy, or investigational treatment (on or off a clinical study) within 30 days prior to treatment
- •3. Pregnant (confirmed by ß -HCG) or lactating female
- •4. Presence of a =grade 2 preexisting skin disorder (except for alopecia)
- •5. Weight loss >10% within 12 weeks prior to the start of study treatment
- •6. History of serious systemic disease, including myocardial infarction within the last 6 months, uncontrolled hypertension (blood pressure >150/100 mmHg on medication), unstable angina, New York Heart Association (NYHA) grade 2 or greater
- •congestive heart failure (CHF), unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible), clinically significant peripheral vascular disease or any current grade 3 or 4 cardiovascular disorder despite treatment
- •7. Documented history of symptomatic brain metastases
- •8. Previous diagnosis of autoimmune disease with significant organ involvement
- •9. History of drug-related acute infusion reaction
- •10. Inability to take oral medication or requirement for intravenous (IV) alimentation or total parenteral nutrition with lipids, or prior surgical procedures affecting absorption
- •11. Presence of another invasive cancer within 5 years prior to start of active treatment, except for adequately treated basal cell skin cancer, or in situ carcinoma of the cervix
- •12. History of significant neurologic or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder) that may impair the subject's understanding of the Informed Consent Form or ability to comply with study requirements
- •13. History of alcohol or substance abuse as defined by the Diagnostic and Statistical Manual (DSM-IV) criteria, within 6 months prior to start of study treatment
- •14. Known conditions that require concurrent treatment with a nonpermitted drug
- •15. Presence of a contraindication to erlotinib according to the labeling for erlotinib
- •16. Known hypersensitivity to the study treatment or any of its components
- •17. Any significant disease that, in the Investigator’s opinion, should exclude the subject from the study
- •18. Legal incapacity or limited legal capacity
研究者
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