EUCTR2012-002962-11-DE进行中（未招募）不适用
Optimizing Pazopanib Exposure in RCC Patients through Therapeutic Drug Monitoring Followed by Intrapatient Dose Escalation - OPERA
Interessenverband zur Qualitätsicherung der Arbeit niedergelassener Uro-Onkologen in Deutschland (IQUO) e.V.0 个研究点开始时间: 2013年3月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-signature of informed consent
- •-age = 18 years
- •-histologically confirmed renal cell carcinoma with clear cell component and either locally progressed or metastasized
- •-ECOG = 2
- •-No previous systemic therapy for locally progressed or metastasized renal cell carcinoma (previous adjuvant or neo-adjuvant therapy is permitted)
- •-Adequate organ function
- •-Female patients with child-bearing potential with negative serum pregnancy test within 2 weeks prior to first dose of study medication and adequate contraception
- •-Lactating females
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Clinically suspected and known metastases of the central nervous system or meningeosis carcinomatosis except in asymptomatic patients with previously treated CNS-metastases and no necessity of steroids or anti-epileptic medication = 6 months prior to start of the study medication
- •- Clinically significant gastrointestinal conditions with risk of increase of gastrointestinal bleeding due to (but not limited to)
- •-active peptic ulceration
- •-known intraluminal metastases with risk of bleeding
- •-chronic-inflammatory intestinal disease (like Morbus Crohn, colitis ulcerosa) or another gastrointestinal disease with increased risk of perforation
- •-abdominal fistulas in anamnesis
- •- Clinically significant gastrointestinal conditions which can influence absorption of the IMP, among others (but not limited to)
- •-malabsorption syndrome
- •-resection of stomach or small bowel
- •- Current uncontrolled infection
- •- QTc corrected for heart frequency according to the Bazett formula
- •- One or more of the following cardiovascular diseases within the last 6 months in the anamnesis:
- •-cardiac angioplasty or coronary stent implantation
- •-myocardial infarction
- •-instable angina pectoris
- •-coronary-arterial bypass surgery
- •-symptomatic peripheral arterial occlusive disease
- •- Heart failure NYHA III or IV
- •- Poorly controlled high blood pressure
- •- Cerebrovascular disease, including transitory ischemic attacks, pulmonary artery embolism or untreated deep vein thrombosis within 6 months of study inclusion
- •- Previous major surgery or traumas within 28 days prior to start if study treatment or non-healing wound, fracture or ulcer
- •- Clinical signs of active bleeding or bleeding diathesis
- •- Known endobronchial lesions or lesions infiltrating the large lung arteries
- •- Haemoptyses of > 2.5 mL within 8 weeks prior to first intake of study medication
- •- Any other severe and/or instable medical or psychiatric pre-existing or other condition influencing patient safety, consent capacity or compliance within the study
- •- Incapacity or rejection to stop not allowed medication prior to first intake of study drug and pause for the duration of the trial
- •- Treatment with one of the following anti-tumour therapies:
- •-Radiation or tumour embolism within 14 days before first intake of study drug
- •-Chemotherapy, Immunotherapy, biological therapy, study medication or hormonal therapy within 14 days or 5 half-lives of the respective substance (whichever is longer) before first intake of the study drug. Neo-adjuvant or adjuvant therapy must have been completed for at least 6 months.
- •-Any present toxicity > CTC 1° from prior anti-tumour therapy and/or toxicities worsening in severity except alopecia
研究者
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