NL-OMON30060已完成不适用
Phase I dose-escalation trial for the combination of sorafenib with interleukin-2 (IL-2) in patients with clear cell renal cancer - M06SI
KI-AV0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients with cytologically or histologically proven RCC, clear cell subtype, with documented progressive disease either after first line, interferon(IFN)-a- or interleukin-2-based therapy or for whom IFN-a-based treatment is not considered appropriate because of prognostic features according to Motzer.
- •- Evaluable and measurable disease (according to RECIST criteria)
- •- Adequate bone marrow, hepatic and renal function
- •- life expectancy of at least 3 months
- •- age of 18 or older
- •- willingness to use a medically approved method of contraception
- •- before patient randomization, written informed consent must be given and documented to ICH/EU GCP, and national/local regulatory requirements and the local rules followed in the institution
排除标准
- •- Uncontrolled or poorly controlled hypertension (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 90 mmHg). Initiation or adjustment of blood pressure medications is permitted prior to study treatment provided that 3 consecutive blood pressure readings are <= 150/90 mmHg, each separated by at least 24 hours
- •- Concurrent therapy with prohibited medication
- •- History of malabsorption syndrome or other disease that could significantly affect absorption of drugs
- •- Other malignancies (previous or current), except adequately treated basal or squamous cell carcinoma of the skin and carcinoma in situ of breast or cervix
- •- Prior treatment with VEGF or VEGF-R targeting agent (monoclonal antibody or tyrosine kinase inhibitor)
- •- Cytotoxic, hormonal, investigational treatment or immunotherapy within 4 weeks prior to day 1 of study treatment
- •- Major surgery within 4 weeks prior to study treatment
- •- Persistent grade 2 or greater toxicity related to prior treatment (except alopecia) (NCI-CTC version 3.0)
- •- History of any infection requiring hospitalisation or antibiotics within 2 weeks prior to study treatment
- •- Systemic steroids within 2 weeks prior to study treatment
- •- Myocardial infarction or cerebrovascular accident (CVA) within 6 months prior to study treatment
- •- Congestive heart failure requiring medication
- •- Known brain metastases
- •- Known human immunodeficiency virus (HIV) infection
- •- Known chronic or acute viral hepatitis
- •- Pregnant or breast-feeding women.
研究者
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