EUCTR2006-005751-16-DE进行中（未招募）不适用
An open label, dose escalation safety and tolerability trial of the combination of s.c. recombinant human IL-21 (rIL-21) and sunitinib (phase 1) followed by an open label stratified randomized 2-arm trial of rIL-21 plus sunitinib versus sunitinib alone (phase 2a) in subjects with stage IV renal cell carcinoma. Trial Phase: 1/2a
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 98
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.Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- •2.Histologically verified and surgically incurable stage IV RCC of clear cell type. (clear cell type only required for phase 2a)
- •3.18 years of age or above
- •4.ECOG performance status of 0 or 1. Please refer to Appendix F.
- •5.Life expectancy of at least 3 months
- •6.0-2 risk factors according to Motzer criteria (favourable or intermediate risk) (1). Please be referred to Appendix D.
- •7.Prior resection of the primary tumour required
- •8.Full recovery from surgery for stage IV disease
- •9.Remaining measurable disease (according to RECIST) required for phase 2a only.
- •Haematopoietic parameters:
- •10.White blood cell (WBC) higher/equal than 2.5 x 10 superscript 9/L
- •11.Absolute neutrophil count (ANC) higher/equal than 1.5 x 10 superscript 9/L
- •12.Platelet count higher/equal than 100 x 10 superscript 9/L
- •13.Haemoglobin higher/equal than 6.2 mmol/L
- •14.No signs of haemolytic anaemia
- •15.Serum creatinine less/equal than 177 µmol/L
- •Hepatic parameters:
- •16.Bilirubin less/equal than 1.25 x upper limit of normal (ULN)
- •17.AST/SGOT less/equal than 2.5 x ULN
- •18.LDH less/equal than 2x upper limit of normal
- •19.Negative serologic testing for Hepatitis B and C
- •20. ALT = 2.5 x ULN
- •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.Previous systemic treatment for stage IV disease
- •2.Rare histological subtypes of RCC (true papillary, collecting duct, sarcomatoid features) applies for phase 2a only
- •3.History of or active presence of auto-immune diseases (except vitiligo and treated pernicious anaemia)
- •4.History of any other active malignancy (except basal cell carcinoma of the skin and cervical cancer in situ) within five years prior to enrolment
- •5.Known chronic infectious disease including human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) related illness
- •6.Any significant systemic disease which according to the Investigator could compromise the safety of the subject or interfere with the trial objectives
- •7.Concurrent treatment with systemic corticosteroids (topical or inhaled corticosteroid treatment is permitted)
- •8.Known or suspected allergy to trial products or related products
- •9.Previous participation in this trial (re-screening is allowed when agreed with the Local Trial Manager or the International Trial Manager)
- •10.Pregnant, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any). In Germany adequate contraception is: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence, or vasectomised partner. No specific requirements in the Netherlands.
- •11.The receipt of any investigational drug within 3 months prior to start on this trial (day 1)
- •12.The receipt of concomitant anti-coagulation therapy Low Molecular Weight (LMW) heparins allowed).
- •13.Cerebrovascular accident or transient ischemic attack within the last 12 months
- •14.Deep venous thrombosis or pulmonary embolism within the last 12 months
- •Cardiac events within the last 12 months, such as:
- •15.Myocardial infarction
- •16.Severe/unstable angina
- •17.Coronary/peripheral artery bypass graft
- •18.Symptomatic congestive heart failure (CHF)
- •Radiotherepy:
- •19. Radiotherapy within the last 4 weeks prior to start of treatment
研究者
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