EUCTR2013-004108-20-NL进行中（未招募）1 期
Improving the tolerability of the oral targeted anti-cancer drug pazopanib by food intake (DIET) - DIET
Radboud University Nijmegen Medical Centre0 个研究点目标入组 79 人开始时间: 2013年12月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 79
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
入选标准
- •1)Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
- •Note: Informed consent may be obtained prior to start of the specified screening window.
- •1)= 18 year old men and women who use pazopanib for soft tissue sarcoma or metastatic renal cell carcinoma
- •2)Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- •3)BMI between 18-30 kg/m2
- •4)Adequate organ system function
- •bsolute neutrophil count (ANC)>1.5 X 109/L
- •Hemoglobina>9 g/dL (5.6 mmol/L)
- •Platelets>100 X 109/L
- •Total bilirubin<2 X ULN
- •Alanine amino transferase (ALT) and Aspartate aminotransferase (AST)c <3 X ULN
- •Serum creatinine<1.5 mg/dL (133 µmol/L)
- •Or, if >1.5 mg/dL: Calculated creatinine clearance (ClCR) >30 mL/min
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •1)Poorly controlled hypertension; systolic blood pressure = 40 mm Hg or diastolic blood pressure = 90 mm Hg.
- •Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals. At least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement. These three values should be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure. The mean SBP / DBP ratio must be <140/90 mmHg (OR 150/90 mm Hg, if this criterion is approved by Safety Review Team) in order for a subject to be eligible for the study.
- •2)Corrected QT interval (QTc) > 480msecs.
- •3)History of any one or more of the following cardiovascular conditions within the past 6 months:
- •Cardiac angioplasty or stenting
- •Myocardial infarction
- •Unstable angina
- •Coronary artery bypass graft surgery
- •Symptomatic peripheral vascular disease
- •Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- •4)Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- •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 intra abdominal abscess within 28 days prior to beginning study treatment.
- •5)Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
- •Malabsorption syndrome.
- •Major resection of the stomach or small bowel.
- •6)History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- •Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible.
- •7)Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
- •8)Evidence of active bleeding or bleeding diathesis.
- •9)Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage.
- •Note: Lesions infiltrating major pulmonary vessels (contiguous tumor and vessels) are excluded; however, the presence of a tumor that is touching, but not infiltrating (abutting) the vessels is acceptable (CT with contrast is strongly recommended to evaluate such lesions).
- •10)Recent hemoptysis (?½ teaspoon of red blood within 8 weeks before first dose of study drug).
- •11)Any serious and/or unstable pre-existing medical, psychiatric
研究者
相似试验
已完成
不适用
Improving the tolerability of the oral targeted anti-cancer drug pazopanib by food intake (DIET).10038364renal cell carcinomaNL-OMON47219Apotheek97
进行中（未招募）
2 期
Establishment of oral care method to reduce the number of bacteria in saliva of patients undergoing cancer surgeryJPRN-jRCT1071230048Soutome Sakiko60
进行中（未招募）
不适用
Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.Active left-sided, mild to moderate ulcerative colitisMedDRA version: 8.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2006-001782-42-HUCosmo Technologies Ltd120
进行中（未招募）
1 期
Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo.EUCTR2006-001782-42-GBCosmo Technologies Ltd120
进行中（未招募）
不适用
Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. - NDEUCTR2006-001782-42-ITCOSMO TECHNOLOGIES LTD120