NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Urothelial Carcinoma
Date of first enrollment	05/10/2015
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Ramucirumab INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : ramucirumab (10 mg/kg) intravenously (I.V.) plus docetaxel (75 mg/m2) I.V.

Outcome(s)

Primary Outcome	Progression-free survival (PFS)
Secondary Outcome	overall survival time objective response rate disease control rate duration of response European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 [EORTC QLQ-C30] and EQ 5D-5L questionnaires the pharmacokinetic profile of ramucirumab the immunogenicity of ramucirumab

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	[1]The patient has histologically or cytologically confirmed, locally advanced or unresectable or metastatic urothelial (transitional cell) carcinoma of the bladder, urethra, ureter, or renal pelvis. [2]The patient has demonstrated disease progression while on a platinum-containing regimen in the first-line setting or within 14 months (more than 14 months) after completing the first line platinum regimen. [3]The patient has a life expectancy of 3 months, in the judgment of the investigator. [4]The patient has received no more than one prior systemic chemotherapy regimen in the relapsed or metastatic setting. [5]The patient has measurable disease or nonmeasurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) [6]The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. [7]The patient has not received blood or blood components transfusion within 2 weeks. [8]The patient has adequate coagulation function [9]The patient has adequate hepatic function [10]The patient does not have: cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. [11]The patient has adequate renal function. [12]The patient's urinary protein is 1+ on dipstick or routine urinalysis [13]The patient is able to provide signed informed consent and is amenable to compliance with protocol schedules and testing.
Exclude criteria	[14]The patient has received more than one prior systemic chemotherapy regimen for metastatic disease. [15]The patient has received prior systemic taxane therapy for TCC of the bladder, urethra, ureter, or renal pelvis in any setting (neoadjuvant, adjuvant, metastatic). [16]The patient has received more than one prior antiangiogenic agent (that is, bevacizumab, sorafenib, sunitinib) for TCC of the urothelium. [17]The patient has received radiation therapy (including full-dose pelvic radiotherapy) within 4 weeks prior to randomization or has not recovered from toxic effects of the treatment that was given 4 weeks prior to randomization. [18]The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders. [19]The patient has experienced a Grade 3 bleeding event within 3 months prior to randomization. [20]The patient has uncontrolled intercurrent illness, including, but not limited to symptomatic anemia, uncontrolled hypertension (160 mm Hg systolic and/or 100 mm Hg diastolic, despite antihypertensive medication), symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness, or any other serious uncontrolled medical disorders in the opinion of the investigator. [21]The patient has experienced any arterial or venothrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 6 months (≤6 months) prior to randomization. [22]The patient has known untreated brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease. [23]The patient has known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome-related illness. [24]The patient has undergone major surgery within 28 days prior to randomization or subcutaneous venous access device placement within 7 days prior to randomization. [25]The patient is pregnant or lactating. [26]The patient has a concurrent malignancy or had another malignancy within 5 years of study enrollment.