EUCTR2011-001138-40-DE进行中（未招募）1 期
First Line Pazopanib in Poor Risk Patients with Metastatic Renal Cell Carcinoma - FLIPPER
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
- iOMEDICO AG
- 入组人数
- 44
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.Histologically confirmed metastatic or locally advanced (defined as non operable tumor), predominantly clear cell renal cell carcinoma.
- •2.At least three of the following six predictors of short survival are required:
- •oLDH > 1.5 x ULN
- •oHemoglobin < LLN
- •ocorrected serum calcium level > 10 mg/dl (2.5 mmol/l)
- •otime from initial diagnosis of renal-cell carcinoma to occurrence of metastases of less than 1 year
- •oKarnofsky Status of 60 or 70
- •3.Karnofsky Status = 60
- •4.Age = 18 years or legal age of consent if greater than 18 years
- •5.Dated and signed written informed consent prior to performance of study-specific procedures or assessments
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •- Other malignancy. (Patients who have undergone prior radical or partial nephrectomy for RCC are allowed). Subjects who have had another malignancy and have been disease-free for five years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
- •- Prior systemic treatment for renal cell carcinoma. (NB: all treatments, neo-adjuvant, adjuvant or for locally advanced or metastatic RCC are not permitted.)
- •- History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug. Screening with CNS imaging studies (computed tomography (CT) or magnetic resonance imaging (MRI) is required only if clinically indicated or if the subject has a history of CNS metastases.
- •- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
- •oActive peptic ulcer disease
- •oKnown intraluminal metastatic lesion/s with risk of bleeding
- •oInflammatory bowel disease (e.g. ulcerative colitis, Chrohn’s disease), or other gastrointestinal conditions with increased risk of perforation
- •oHistory of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment
- •- History of any one or more of the following cardiovascular conditions within the past 6 months:
- •oMyocardial infarction
- •oCardiac angioplasty or stenting
- •oUnstable angina
- •oCoronary artery bypass graft surgery
- •oSymptomatic peripheral vascular disease
- •oClass III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- •- Poorly controlled hypertension (defined as systolic blood pressure (SBP) of =140 mmHg or diastolic blood pressure (DBP) of = 90mmHg). Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions at intervals of at least one hour if it is not <140/90 mmHg at baseline assesment. On each of these occasions, SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study
- •- Pregnant or breast-feeding women
- •- Known hypersensitive reaction to any of the components of study treatments
研究者
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