An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 or Without Investigational Therapy as Second-line Therapy in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Bladder, Urethra, Ureter, or Renal Pelvis Following Disease Progression on First-line Platinum-based Therapy

Eli Lilly and Company1 个研究点分布在 1 个国家目标入组 148 人开始时间: 2011年4月最近更新: 2019年9月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Eli Lilly and Company
入组人数: 148
试验地点: 1
主要终点: Progression-Free Survival (PFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This multicenter trial will enroll participants with metastatic transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis who have had disease progression on first-line platinum-based chemotherapy regimens. Participants will be enrolled into 1 of 3 treatment arms: docetaxel; docetaxel and ramucirumab; or docetaxel and icrucumab.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically or cytologically confirmed transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
•Locally advanced or metastatic and unresectable transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
•Had treatment with a platinum-containing regimen
•Disease progression within 12 months of after receiving the last dose of a platinum containing regimen in the neoadjuvant or adjuvant setting, and/or had disease progression while on a platinum-containing regimen or within 12 months after the last dose of therapy in the locally advanced or metastatic setting
•Has measurable or nonmeasurable disease
•Life expectancy of ≥ 3 months
•Received no more than 2 prior systemic chemotherapy regimens in any setting
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
•Has adequate hematologic, coagulation, hepatic and renal function
•Does not have:
•cirrhosis at a level of Child-Pugh B (or worse)
•cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
•If female, is surgically sterile, postmenopausal, or compliant with a highly effective contraceptive method during and for 12 weeks after the treatment period
•If male, the patient is surgically sterile or compliant with a contraceptive regimen during and for 12 weeks after the treatment period

排除标准

•Received more than one prior systemic treatment regimen for metastatic disease
•Received prior systemic taxane therapy (except for prior paclitaxel therapy) for Transitional Cell Carcinoma of the bladder, urethra, ureter, or renal pelvis in any setting (neoadjuvant, adjuvant, metastatic). Prior intravesical taxane therapy is allowed
•Has received more than one prior anti-angiogenic agent for Transitional Cell Carcinoma of the bladder, urethra, ureter, or renal pelvis
•Has received radiation therapy within 4 weeks prior to randomization
•Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
•Has experienced a Grade ≥ 3 bleeding event (eg, via gastric ulcers, gastric varices, or gross hematuria) within 3 months prior to randomization
•Has uncontrolled intercurrent illness including, but not limited to symptomatic anemia, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
•Has experienced any arterial thrombotic or thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack or cerebrovascular accident, within 6 months prior to randomization
•Has known brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
•Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
•Has known human immunodeficiency virus infection or acquired immunodeficiency syndrome
•Has received a prior autologous or allogeneic organ or tissue transplantation
•Received chemotherapy within 21 days prior to randomization; and/or is currently enrolled in, or discontinued within 21 days prior to randomization from, a clinical trial involving an investigational product or unapproved use of a drug or device (other than the study drug[s] used in this study), or is concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study; and/or was treated with anti-angiogenic therapy within 28 days prior to randomization
•Has undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
•Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
•Has an elective or planned major surgery to be performed during the course of the trial
•Is pregnant or lactating
•Has a concurrent active malignancy other than adequately treated non-melanomatous skin cancer, curatively treated cervical carcinoma in-situ, other noninvasive carcinoma or in-situ neoplasm, or prostate cancer with an undetectable prostate specific antigen (PSA) and no current treatment with hormone therapy
•Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
•History of gastrointestinal perforation and/or fistula within 6 months prior to randomization
•Has active diverticulitis
•Known hypersensitivity to docetaxel or other drugs formulated with polysorbate 80
•Known hypersensitivity to agents of similar biologic composition as ramucirumab DP, IMC-18F1, or other agents that specifically target vascular endothelial growth factor receptor (VEGF)