EUCTR2010-019318-26-IT进行中（未招募）不适用
A multicenter, Randomized, Double-Bind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- IMCLONE LLC
- 入组人数
- 544
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. The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing. 2. The patient is at least 18 years of age. 3. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 4. The patient has a Child-Pugh score of < 9 (Child-Pugh A or B [B7 or B8]). 5. The patient has a Barcelona Clinic Liver Cancer (BCLC) stage C at randomization. A patient with BCLC stage B may be eligible if he/she has disease that is not amenable to locoregional therapy or is refractory to locoregional therapy (examples include very large or diffusely infiltrative tumors and intrahepatic tumors that are refractory to transarterial chemoembolization [TACE] or not amenable to TACE). 6. The patient has a diagnosis of HCC (excluding fibrolamellar carcinoma) based on histopathologic or cytologic findings; or in the absence of histologic confirmation, all of the following are present (at the time of study entry): a. There are either clinical, laboratory, or radiographic findings consistent with a diagnosis of liver cirrhosis, b. The patient has a liver mass measuring at least 2 cm with characteristic vascularization (intense inhomogeneous enhancement seen in the hepatic arterial-dominant phase and contrast washout in the late portal venous phase) seen on either triphasic computed tomography (CT) scan or magnetic resonance imaging (MRI) with gadolinium, c. The patient has a serum alpha-fetoprotein (AFP) concentration greater than the institutional upper limit of normal (ULN). For the complete list of inclusion criteria please refer to the Protocol
- •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. The patient (P) has undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. 2. Hepatic locoregional therapy (including radiation, surgery, hepatic arterial embolization, chemoembolization, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 28 days prior to randomization 3. Radiation to any nonhepatic site within 14 days prior to randomization 4. Sorafenib within 14 days prior to randomization 5. Any investigational therapy within 28 days prior to randomization 6. Any previous systemic therapy with vascular endothelial growth factor inhibitors or vascular endothelial growth factor receptor inhibitors (including investigational agents) other than sorafenib for treatment of HCC. For the complete list of exclusion criteria please refer to the Protocol
研究者
相似试验
进行中（未招募）
不适用
A Phase 3, Multicenter, Randomized, and Double-blind Study to Evaluate the Safety of Tigecycline versus a Ceftriaxone Regimen in the Treatment of Complicated Intra-abdominal Infections and Community-acquired Pneumonia in Pediatric Subjects Ages 8 to 17 Years OldComplicated Intra-Abdominal InfectionMedDRA version: 14.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2008-005166-31-Outside-EU/EEAWyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company300
进行中（未招募）
1 期
A Phase 3, Multicenter, Randomized, and Double-blind Study to Evaluate the Safety of Tigecycline versus a Ceftriaxone Regimen in the Treatment of Complicated Intra-abdominal Infections and Community-acquired Pneumonia in Pediatric Subjects Ages 8 to 17 Years OldMedDRA version: 9.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionComplicated Intra-Abdominal InfectionEUCTR2008-005166-31-HUWyeth Pharmaceuticals, Inc.300
进行中（未招募）
1 期
A Phase 3, Multicenter, Randomized, and Double-blind Study to Evaluate the Safety of Tigecycline versus a Ceftriaxone Regimen in the Treatment of Complicated Intra-abdominal Infections and Community-acquired Pneumonia in Pediatric Subjects Ages 8 to 17 Years OldMedDRA version: 9.1Level: LLTClassification code 10056570Term: Intra-abdominal infectionComplicated Intra-Abdominal InfectionEUCTR2008-005166-31-SIWyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company300
进行中（未招募）
1 期
A Phase 3, Multicenter, Randomized, and Double-blind Study to Evaluate the Safety of Tigecycline versus a Ceftriaxone Regimen in the Treatment of Complicated Intra-abdominal Infections and Community-acquired Pneumonia in Pediatric Subjects Ages 8 to 17 Years OldComplicated Intra-Abdominal InfectionEUCTR2008-005166-31-BEWyeth Pharmaceuticals Inc., acting through its division Wyeth Research, a Pfizer Company300
进行中（未招募）
1 期
A Phase 3, Multicenter, Randomized, and Double-blind Study to Evaluate the Safety of Tigecycline versus a Ceftriaxone Regimen in the Treatment of Complicated Intra-abdominal Infections and Community-acquired Pneumonia in Pediatric Subjects Ages 8 to 17 Years OldMedDRA version: 9.1 Level: LLT Classification code 10056570 Term: Intra-abdominal infectionComplicated Intra-Abdominal InfectionEUCTR2008-005166-31-GBWyeth Pharmaceuticals Inc., Acting through its division Wyeth Research, a Pfizer Company300