EUCTR2006-000899-32-DE进行中（未招募）不适用
Randomized, phase II, open-label controlled study of two different doses and schedules of EMD 72000 (matuzumab) in combination with pemetrexed, or pemetrexed alone, as second-line treatment in subjects with Stage IIIB/IV non-smallcell lung cancer and progressive disease on or after first-line treatment with a platinum analogue in combination with either taxanes, gemcitabine or vinorelbine
EMD Pharmaceuticals, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany)0 个研究点目标入组 150 人开始时间: 2006年4月28日最近更新:
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
- 入组人数
- 150
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. Written informed consent provided prior to any screening procedure
- •2. Male or female, =18years of age
- •3. Histologically or cytologically confirmed diagnosis of NSCLC
- •4. Demonstrated progressive disease on or after first-line chemotherapy for Stage IIIB/IV disease. The first-line therapy must consist of platinum-based regimens in
- •combination with taxanes, gemcitabine or vinorelbine. Stage IIIB patients must have measurable disease (tumor) without clinically significant pleural effusion unless the pleural
- •can be effectively drained prior to admission into the study.
- •5. A chemotherapy-free interval of at least 3 weeks between the end of first-line chemotherapy and start of study treatment
- •6. At least 1 measurable lesion according to the modified WHO criteria as defined in Section 7.2.2
- •7. Archived tissue or cytologic sample available for the determination of EGFR expression
- •8. ECOG performance status 0-1
- •9. Life expectancy >12 weeks
- •10. Adequate baseline organ functions, defined as follows:
- •Serum creatinine =1.5 × upper limit of normal (ULN)
- •In case of borderline values for serum creatinine, creatinine clearance must be =45 mL/min
- •Total bilirubin <1.5 × ULN
- •Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =2.5 × ULN (Subjects with liver metastases should have ALT/AST <5 × ULN.)
- •Absolute neutrophil count =1500/mm3
- •Platelet count =100,000/mm3
- •Hemoglobin level =10 g/dL
- •11. If procreative potential (male or female), willingness to use effective contraceptive methods for the duration of treatment and continuing for 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).
- •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. Radiotherapy or major surgery within 30 days prior to the start of study treatment
- •2. Prior treatment with an EGFR-directed therapy or with EGFR signal transduction inhibitors
- •3. Prior treatment with pemetrexed
- •4. Pregnant (confirmed by ß-HCG) or lactating female
- •5. Weight loss >10% within 12 weeks prior to the start of study treatment
- •6. Documented or symptomatic brain metastases or leptomeningeal disease
- •7. Myocardial infarction within 6 months prior to the start of study treatment, uncontrolled congestive heart failure, or any current New York Heart Association
- •Grade III or IV cardiovascular disorder despite treatment
- •8. Presence of a =Grade 2 preexisting skin disorder (except for alopecia)
- •9. Previous diagnosis of autoimmune disease with significant organ involvement
- •10. Concurrent malignancies or invasive carcinomas diagnosed within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in
- •situ carcinoma of the cervix
- •11. Any significant disease that, in the Investigator’s opinion, should exclude the subject from the study
- •12. History of significant neurologic or psychiatric disorder (e.g., dementia, seizures, or bipolar disorder)
- •13. History of drug abuse within 6 months prior to the start of study treatment
- •14. Known conditions that require concurrent treatment with a nonpermitted drug (see Section 6.8.2 of the protocol)
- •15. Presence of a contraindication to the study treatment(s) according to the current Investigator’s Brochure (IB) for matuzumab and the labeling for pemetrexed
- •16. Known hypersensitivity to the study treatment or any of its components
- •17. Participation in another clinical study within 30 days prior to the start of study treatment
- •18. Legal incapacity or limited legal capacity
研究者
相似试验
进行中（未招募）
不适用
Randomized, phase II, open-label controlled study of two different doses and schedules of EMD 72000 (matuzumab) in combination with pemetrexed, or pemetrexed alone, as second-line treatment in subjects with Stage IIIB/IV non-smallcell lung cancer and progressive disease on or after first-line treatment with a platinum analogue in combination with either taxanes or gemcitabineEUCTR2006-000899-32-ATEMD Pharmaceuticals, Inc. (an affiliate of Merck KGaA, Darmstadt, Germany150
进行中（未招募）
1 期
Phase II study of PM060184 in Advanced Breast Cancer Patients in Third or Fourth Line.MedDRA version: 19.0Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Breast CancerEUCTR2015-002395-24-BEPharma Mar, S.A.106
进行中（未招募）
1 期
Phase II study of PM060184 in Advanced Breast Cancer Patients in Third or Fourth Line.MedDRA version: 18.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864Breast CancerEUCTR2015-002395-24-ESPharma Mar, S.A. , Sociedad Unipersonal106
尚未招募
2 期
Clinical trial of ShatPlus as an immunomodulator in adult Covid 19 positive patientsCTRI/2020/06/025999BVG Life Sciences Ltd
招募中
2 期
Clinical trial of ACT 12 tablet and ACT 13 dry syrup in Covid 19 patientsCTRI/2020/07/026630Mr Ghanshyam Goti