EUCTR2007-003989-18-NL进行中（未招募）1 期
A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy - AMR PH GL 2007 CL 001
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
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. Histological or cytological diagnosis of SCLC at study entry according to the International Association for the Study of Lung Cancer (IASLC) histopathologic classification. Mixed or combined subtypes according to the IASLC are not allowed;
- •2. SCLC that is either sensitive (defined as a response to first-line platinum-based
- •chemotherapy, with subsequent progression = 90 days after completing chemotherapy) or refractory (defined as no objective response to prior platinum-based therapy or progression < 90 days after completing prior platinum-based therapy);
- •3. Extensive or limited disease; however, patients with limited disease who are candidates for local or regional salvage radiation therapy must have been offered such treatment prior to participation in this study;
- •4. Radiographically documented progression after first-line treatment with platinum-based chemotherapy;
- •5. No more than 1 prior chemotherapy regimen;
- •6. At least 18 years of age;
- •7. ECOG performance status of 0, 1, or 2.
- •8. Measurable disease defined by modified RECIST as follows:
- •a. Measurable disease: The presence of at least 1 measurable lesion,
- •b. Measurable lesion: Lesions that can be accurately measured in at least
- •1 dimension with the longest diameter = 20 mm using conventional techniques,
- •or = 10-16 mm, depending on reconstruction interval, using spiral computed
- •tomography (CT) scans;
- •9. Adequate organ function including the following:
- •a. Adequate bone marrow reserve: absolute neutrophil count (segmented and
- •bands) (ANC) = 1.5 x 10^9/L, platelet count = 100 x 10^9/L, and hemoglobin = 90 g/L,
- •b. Hepatic: bilirubin = 1.5 x the upper limit of normal (ULN), ALT and AST = 3.0 x ULN,
- •c. Renal: serum creatinine = 1.5 x ULN or calculated creatinine clearance > 60 L/min,
- •d. Cardiac: Left ventricular ejection fraction (LVEF) = the lower limit of the institutional normal by echocardiogram (ECHO) or multiple gated acquisition
- •scan (MUGA);
- •10. Negative serum pregnancy test at the time of enrollment for females of childbearing potential;
- •11. For males and females of child-producing potential, use of effective contraceptive
- •methods during the study;
- •12. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, to understand and complete QoL forms, and agree to abide by the study restrictions and to return for the required assessments.
- •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
- •Patients meeting any of the following criteria will be excluded from the study:
- •1. Pregnant or nursing females;
- •2. Chest radiotherapy with curative intent to the primary disease complex = 28 days prior to first dose; cranial radiotherapy = 21 days prior to first dose; radiotherapy to all other areas = 7 days prior to first dose;
- •3. Prior anthracycline, topotecan or irinotecan treatment;
- •4. Treatment with any investigational agent within 28 days or standard chemotherapy within 21 days prior to first dose. Patients must have recovered from all acute adverse effects of prior therapies, excluding alopecia;
- •5. Patients with previous malignancy treated with chemotherapy and/or radiation (except in situ carcinoma of the cervix, localized low-grade prostate cancer, adequately treated non-melanomatous skin cancer, or ductal carcinoma in situ [DCIS] of the breast). Patients with a previous malignancy that was treated surgically at least 3 years prior and who have been in remission since that time will be allowed;
- •6. Concurrent severe or uncontrolled medical disease (eg, active systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study;
- •7. Symptomatic central nervous system metastases. Patients with asymptomatic brain metastases are allowed. The patient must be stable for = 2 weeks after radiotherapy ; if the patient is on corticosteroids, the dose of corticosteroids must have been stable for = 2 weeks prior to first dose of study treatment, or be in the process of being tapered;
- •8. Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis not related to prior treatment.
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line ChemotherapyEUCTR2007-003989-18-DECelgene Corporation620
进行中（未招募）
不适用
A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line ChemotherapyExtensive or limited and sensitive or refractory SCLC after failure of first-linechemotherapy.MedDRA version: 9.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedEUCTR2007-003989-18-DKCelgene Corporation620
进行中（未招募）
不适用
A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line ChemotherapyExtensive or limited and sensitive or refractory SCLC after failure of first-linechemotherapy.MedDRA version: 9.1Level: LLTClassification code 10041071Term: Small cell lung cancer stage unspecifiedEUCTR2007-003989-18-ATCelgene Corporation620
进行中（未招募）
不适用
A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line ChemotherapyEUCTR2007-003989-18-GBCelgene Corporation620
进行中（未招募）
不适用
A Randomized, Open-Label, Multinational Phase 3 Trial Comparing Amrubicin Versus Topotecan in Patients With Extensive or Limited and Sensitive or Refractory Small Cell Lung Cancer After Failure of First-Line Chemotherapy - AMR PH GL 2007 CL 001EUCTR2007-003989-18-ITPHARMION CORPORATIO480