EUCTR2010-023406-13-DE进行中（未招募）不适用
Target-spezifische Therapie mit Pazopanib zusätzlich zu Vinflunin bei Patienten mit fortgeschrittenem oder metastasiertem Urothelkarzinom nach Versagen einer platinhaltigen Therapie
Städtische Kliniken Neuss, Lukaskrankenhaus GmbH0 个研究点目标入组 80 人开始时间: 2010年12月28日最近更新:
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
- 80
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. Written informed consent
- •2. Age = 18 years
- •3. Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) with lymphatic (N-stage 2-3) and/or distant metastases (M-stage 1) not amenable to definitive regional/local therapy
- •4. Progression of tumor disease after platinum containing systemic chemotherapy for advanced or metastatic disease
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 1
- •6. estimated minimal life expectancy of 3 months at screening
- •7. At least one measurable tumor lesion according to RECIST 1.1 criteria
- •8. Adequate organ system function at screening
- •9. Adequate contraception
- •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. More than 1 prior chemotherapy, biologic therapy or hormonal therapy within 14 days prior to the first dose of study medication
- •2. Prior malignancy within 5 years prior to inclusion (exception: successfully treated basal cell carcinoma or in situ carcinoma)
- •3. History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis
- •4. Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 28 days prior to beginning study treatment, e.g
- •Active peptic ulcer disease
- •Known intraluminal metastatic lesion/s with risk of bleeding
- •Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation
- •History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess
- •5. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product, e.g.
- •Malabsorption syndrome
- •Major resection of the stomach or small bowel
- •6. Active infection requiring antibiotics within 14 days before registration
- •7. Corrected QT interval (QTc) > 480 msecs using Bazett’s formula at screening
- •8. Screening-electrocardiogram (ECG) with any significant modifi¬cations suggesting a high risk of occurrence of an acute clinical event (such as signs of angina pectoris, high risk arrhythmia etc.)
- •9. History of one or more of the following cardiac / cardiovascular conditions within the past 6 months before registration:
- •Cardiac angioplasty or stenting
- •Myocardial infarction
- •Unstable angina
- •Coronary artery bypass graft surgery
- •Symptomatic peripheral vascular disease
- •NYHA Class II, III or IV congestive heart failure
- •Uncontrolled cardiac arrhythmia
- •10. Poorly controlled hypertension, defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90 mmHg
- •11. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months before registration
- •12. Peripheral neuropathy grade = 2 (NCI CTC v3.0)
- •13. Unstable diabetes mellitus
- •14. Uncontrolled hypercalcaemia > 2.9 mmol/L
- •15. Prior major surgery or trauma within 28 days prior to registration and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major)
- •16. Evidence of active bleeding e.g. GI bleeding or bleeding diathesis at screening.
- •17. Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- •18. Hemoptysis with bleeding of > 2.5 mL within 8 weeks before registration
- •19. Any serious and/or unstable pre-existing medical, psychiatric/psychological, familial, sociological, geographical or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures
- •20. Inability or unwillingness to discontinue use of prohibited medications prior to the first dose of study drug and for the duration of the study
- •21. Radiation, surgery or tumor embolization or any investigational treatment within 14 days prior to the first dose of study medication
- •22. Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or progressing in severity, except nausea, vomiting, alopecia
- •24. Pre-treatment with Pazopanib or Vinflunine
- •25. Pregnancy or lactation
研究者
相似试验
已完成
不适用
Personalized therapy for pazopanib by pharmacokinetic analysis in patients with renal cell carcinoma or malignant soft tissue tumorRenal cell carcinoma Malignant soft tissue tumorJPRN-UMIN000034034Tohoku Medical and Pharmaceutical University14
进行中（未招募）
1 期
PAZOBONE: Clinical trial investigating the efficacy of Pazopanib in untreated metastatic renal cell carcinoma patients with bone metastasesEUCTR2017-003706-40-ITFONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI88
进行中（未招募）
1 期
Individualizing Pazopanib therapy by exploRing the role of Early metabolic responsE and drug exposure as a preDICTor for treatment outcome in patients with STSsoft tissue sarcoma patientsEUCTR2013-003533-16-NLRadboud University Nijmegen Medical Centre30
招募中
4 期
Individualizing Pazopanib therapy by exploRing the role of Early metabolic responsE and drug exposure as a preDICTor for treatment outcome in patients with STSSoft tissue sarcom10072990NL-OMON41252Medische Oncologie30
尚未招募
2 期
Combination oral chemotherapy in advanced ovarian cancerCTRI/2017/10/010219Aparna Sharma