EUCTR2007-004574-11-DE进行中（未招募）不适用
RANDOMISED, DOUBLE-BLINDED, PLACEBO- CONTROLLED PHASE 2 STUDY OF CS-1008 IN COMBINATION WITH CARBOPLATIN/PACLITAXEL IN CHEMOTHERAPY NAÏVE SUBJECTS WITH METASTATIC OR UNRESECTABLE NON-SMALL CELL LUNG CANCER
Daiichi Sankyo Development Limited0 个研究点目标入组 120 人开始时间: 2007年12月7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
- 120
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. Histologically or cytologically confirmed, stage IIIB wet or stage IV NSCLC.
- •2. At least 18 years of age.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- •4. Measurable disease as defined by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.
- •5. Adequate organ and bone marrow function as evidenced by:
- •- Hemoglobin >/= 9 g/dL;
- •- Absolute neutrophil count >/= 1.5 x 10(e +9)/L;
- •- Platelet count >/= 100 x 10(e +9)/L;
- •- Serum creatinine < 1.5 mg/dL or creatinine clearance > 60 mL/min;
- •- AST, ALT, and alkaline phosphatase = 5.0 x ULN if liver or bone metastasis;
- •- Total bilirubin 6. Women of childbearing potential and men must be willing to consent to using highly effective methods of
- •contraception (eg, hormonal contraceptives, bilateral tubal ligation, barrier with spermicide, intrauterine device)
- •while on treatment and for at least 3 months thereafter.
- •7. Males with the potential to father children and women of childbearing potential must use two of the following
- •methods of contraception acceptable for the study (eg, hormonal contraceptives, bilateral tubal ligation, barrier
- •with spermicide, intrauterine device) while on trial treatment and for at least 3 months thereafter.
- •8. All female subjects of childbearing potential must have a negative pregnancy test (serum or urine) result = 72
- •hours before initiating study treatment.
- •9. Subjects must be fully informed about their illness and the investigational nature of the study protocol
- •(including foreseeable risks and possible side effects) and must sign and date an independent ethics committee
- •(IEC)-approved informed consent
- •form (ICF) before performance of any study-specific procedures or tests.
- •10. Life expectancy of at least 12 weeks.
- •Note: symbol >/= is for greater or equal to.
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 69
排除标准
- •1. Anticipation of need for a major surgical procedure or radiotherapy (RT) during the study for NSCLC.
- •2. No recurrent NSCLC or presence of clinically significant ascites.
- •3. Prior treatment with chemotherapy investigational medicinal products, or biological treatment for NSCLC.
- •4. Prior radiotherapy with curative intent for NSCLC.
- •5. Palliative radiotherapy for NSCLC within 4 weeks prior to first dose.
- •6. Major surgery within 4 weeks prior to first dose.
- •7. History of any of the following conditions within 6 months before study enrolment: myocardial infarction;
- •New York Heart Association (NYHA) class II or higher severe/unstable angina pectoris; coronary/peripheral
- •artery bypass graft; NYHA class III or IV congestive heart failure; cerebrovascular accident or transient
- •ischemic attack, pulmonary embolism, or other clinically significant thromboembolic event; clinically significant
- •pulmonary disease (eg, severe chronic obstructive pulmonary disease or asthma); clinically significant
- •pulmonary edema or anasarca.
- •8. Clinically significant pleural or pericardial effusions.
- •9. Grade 2 or higher current peripheral neuropathy
- •10. Clinically active brain metastasis (ie, untreated, still requiring therapy with steroids or RT, or with progression
- •within 4 weeks after completion of RT); an uncontrolled seizure disorder; spinal cord compression; or
- •carcinomatous meningitis.
- •11. History of malignancy other than NSCLC, unless there is the expectation that the malignancy has been cured,
- •and tumor-specific treatment for the malignancy has not been administered within the previous 5 years.
- •12. Clinically significant active infection that requires antibiotic therapy or Human Immunodeficiency Virus
- •(HIV)-positive subjects receiving antiretroviral therapy.
- •13. Previous treatment with CS-1008, other agonistic DR 5 or DR 4 antibodies, or with TRAIL.
- •14. Pregnant or breast feeding.
- •15. Known history of hypersensitivity reactions to any of the components of CS-1008, carboplatin, or paclitaxel
- •formulations.
- •16. Serious intercurrent medical or psychiatric illnesses or any other conditions that in the opinion of the
- •Investigator would impair the ability to give informed consent or unacceptably reduce protocol compliance or
- •safety of the study treatment.
研究者
相似试验
进行中（未招募）
不适用
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III, SUPERIORITY TRIAL TO ASSESS THE EFFICACY AND SAFETY OF ACETYL-L-CARNITINE IN COMBINATION WITH A CISPLATIN CONTAINING CHEMOTHERAPY AS FIRST LINE TREATMENT OF ADVANCED OR METASTATIC NON SMALL CELL LUNG CANCER - NDEUCTR2010-022021-15-ITIST. DI RICERCHE FARMACOLOG. M. NEGRI
进行中（未招募）
不适用
DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFECT OF A 4-WEEK TREATMENT WITH ORAL DOSES OF MEN15596 IN IRRITABLE BOWEL SYNDROME - NDMedDRA version: 9.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersirritable bowel syndromeEUCTR2008-000214-71-ITaboratorios Menarini S.A. - Menarini Group560
进行中（未招募）
不适用
RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTINATIONAL, MULTI-CENTRE, PHASE IIB/III STUDY OF THE EFFICACY AND SAFETY OF THREE DOSES OF SLIT ADMINISTERED AS TABLETS ONCE DAILY TO PATIENTS SUFFERING FROM GRASSES POLLEN RHINOCONJUNCTIVITISEUCTR2004-001910-15-ITSTALLERGENES
进行中（未招募）
不适用
DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED PROSPECTIVE MULTI-CENTRE PHASE III TRIAL TO ASSESS THE EFFICACY AND SAFETY OF METHANTHELINIUM BROMIDE (VAGANTIN®) IN THE TREATMENT OF FOCAL PALMAR-AXILLARY HYPERHIDROSISTreatment of patients with axillary and palmar hyperhidrosisEUCTR2007-007055-13-DERIEMSER Arzneimittel AG336
未知
不适用
A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF PIRFENIDONE IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSISPER-071-11InterMune, Inc.,44