EUCTR2011-001098-16-GB进行中（未招募）不适用
STAR: A Randomised Multi-Stage Phase II/III trial of Sunitinib comparing Temporary cessation with Allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced and/or metastatic Renal cancer - STAR-Standard vs Modified Sunitinib Treatment in Renal Cancer V1.0
niversity of Leeds0 个研究点目标入组 1,000 人开始时间: 2011年5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
- 入组人数
- 1,000
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.Male or female aged = 18 years old
- •2.Histological confirmation of predominantly clear cell renal cell cancer
- •3.Inoperable loco-regional and/or metastatic disease
- •4.No prior systemic therapy for advanced disease (inoperable loco-regional and/or metastatic disease)
- •5.Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •6.Uni-dimensionally measurable disease (RECIST criteria)
- •7.Full blood count:
- •Haemoglobin (Hb) = 9 g/dl
- •Absolute Neutrophil Count (ANC) = 1 x 109/l
- •Platelets = 80 x 109/l
- •8.Renal biochemistry:
- •Measured or calculated GFR = 30 ml/min
- •9.Hepatobiliary function
- •Aspartate transaminase (AST) or alanine transaminase (ALT) = 2.5 x ULN
- •Bilirubin (BR) = 1.5 x ULN, or = x3 x ULN and direct BR = 35% in patients with Gilbert’s syndrome
- •10.Able to provide written informed consent prior to any trial-specific procedures
- •11.Able and willing to comply with the terms of the protocol including:
- •commencement of sunitinib within 3 days of randomisation
- •temporarily stopping sunitinib if randomised to the DFIS arm
- •capable of oral self-medication
- •capable of reporting toxicity and completing quality of life (QoL) and medical resource utilisation (MRU) questionnaires
- •12.If female and of child-bearing potential, must:
- •have a negative pregnancy test within 72 hours prior to randomisation, and not be breast-feeding
- •agree to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptive under the supervision of a General Practitioner or Family Planning Clinic) during, and for 6 months after the last dose of sunitinib
- •13.If male with a partner of child bearing potential, must
- •agree to use adequate, medically approved, contraceptive precautions (oral or barrier contraceptive under the supervision of a General Practitioner or Family Planning Clinic) during, and for 6 months after the last dose of sunitinib
- •Allowed situations include:
- •primary renal cancer in-situ or previous nephrectomy,
- •previous brain metastases treated with complete surgical resection or gamma knife with no subsequent evidence of progression (patients treated with whole brain radiotherapy are not eligible)
- •previous treatment in the SORCE study providing on placebo arm and NOT active sorafenib arms (The SORCE trial is investigating whether treatment of renal cancer with sorafenib (also a tyrosine kinase inhibitor [TKI]) in the adjuvant setting is effective in reducing development of metastases in high risk patients compared with placebo. By agreement with the Chief Investigator of the SORCE trial, patients who have previously participated in SORCE and have progressed and are no longer on the SORCE trial, will be eligible for STAR, subject to confirmation (through unblinding) that that they received placebo and not active drug (sorafenib) on the SORCE study.
- •previous radiotherapy and/or previous/ongoing bisphosphonates or bone- resorptive drugs (e.g. denosumab) for the treatment of symptomatic bony metastasis.
- •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.Pulmonary or mediastinal disease causing obstruction or bleeding/haemoptysis
- •2.Patients with an estimated life expectancy of < 6 months
- •3.Known contraindications to sunitinib
- •4.No previous treatment with sunitinib or other tyrosine kinase inhibitor (including in the adjuvant setting)
- •5.Untreated brain metastases
- •6.Any concurrent or previous other invasive cancer that could confuse diagnosis (non-melanomatous skin cancer or superficial bladder cancer acceptable, for all other cases please discuss with CTRU)
- •7.Hypersensitivity to sunitinib
- •8.Any concomitant medication or substances forming part of local ongoing care known to significantly affect, or have the potential to significantly affect, the activity or pharmacokinetics of sunitinib (see section 10.2 for further information on concomitant medications)
- •9.Poorly controlled hypertension despite maximal medical therapy
- •10.Any other serious medical or psychiatric condition which in the opinion of the investigator could affect participation in the STAR trial, including gastro-intestinal abnormalities limiting effectiveness of orally administrated drugs, uncontrolled infections, current or recent history of clinically significant cardiovascular disease which, in the opinion of the local investigator, would render the patient unsuitable for standard sunitinib therapy
研究者
相似试验
进行中（未招募）
不适用
A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic MelanomaEUCTR2007-001421-10-DESynta Pharmaceuticals Corp.630
进行中（未招募）
不适用
A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic MelanomaStage IV Metastatic MelanomaMedDRA version: 9.1Level: LLTClassification code 10027480Term: Metastatic malignant melanomaEUCTR2007-001421-10-FRSynta Pharmaceuticals Corp.630
进行中（未招募）
不适用
A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic MelanomaEUCTR2007-001421-10-BESynta Pharmaceuticals Corp.630
进行中（未招募）
不适用
A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic MelanomaEUCTR2007-001421-10-GBSynta Pharmaceuticals Corp.630
进行中（未招募）
1 期
A Randomized, Double-Blind, Phase III Trial of STA-4783 in Combination with Paclitaxel versus Paclitaxel Alone for Treatment of Chemotherapy-Naïve Subjects with Stage IV Metastatic MelanomaStage IV Metastatic MelanomaMedDRA version: 9.1Level: LLTClassification code 10027480Term: Metastatic malignant melanomaEUCTR2007-001421-10-CZSynta Pharmaceuticals Corp.630