EUCTR2006-004024-37-IT进行中（未招募）1 期
SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): ARANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIBVS. PLACEBO IN SUBJECTS WITH HIGH RISK RCC - ND
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 入组人数
- 615
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.Subjects must sign and date IRB/IEC-approved informed consent
- •2. Age >/= 18 years
- •3. ECOG Performance Status 0 ? 2 prior to nephrectomy
- •4. Subjects must be diagnosed in the high risk UISS staging system with one of the
- •a. T3 N0 or Nx, M0, Fuhrman?s grade >/= 2 and ECOG general status >/= 1, or
- •b. T4 N0 or Nx, M0, any Fuhrman?s grade and any ECOG general status, or
- •c. Any T, N1-2, M0, any Fuhrman?s grade and any ECOG general status
- •5. Subjects must have histologically confirmed preponderant clear cell RCC
- •6. Subjects must have no evidence of macroscopic residual disease or metastatic disease
- •Subjects having evidence for microscopic disease (R1) are acceptable
- •7. Subjects must not have received any specific medical previous systemic treatment for
- •8. Subjects must not have received any previous anti-angiogenic treatment
- •9. Subjects must receive the first oral dose of sunitinib not more than 10 weeks after
- •date of nephrectomy (see Appendix 6 for Nephrectomy Procedure).
- •10. Subjects must have adequate organ function defined as:a. Platelets >/= 100 x 10(9)/L, hemoglobin >/= 8 g/dl, absolute neutrophil count (ANC)
- •>/=1.5 x 10(9)/L;
- •b. Bilirubin (ALT) c. International Normalize Ratio (INR) d. Calculated creatinine clearance >/= 30 ml/min.
- •11. Sufficient left ventricular ejection function (LVEF) defined as >/=50% 3 to 10 weeks
- •after date of nephrectomy based on 2-D echocardiogram (ECHO) or multigated
- •acquisition MUGA
- •12. Women and men must use adequate contraception during the study. Acceptable
- •contraception includes implants, injectables, combined oral contraceptives, effective
- •intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner or
- •vasectomy. 13. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
- •tests, and other study procedures.
- •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. Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma,
- •sarcoma or subjects with metastatic renal sites.
- •2. NCI CTCAE grade 3 hemorrhage <4 weeks of date of randomization.
- •3. Diagnosis of any second malignancy within the 5 years from date of randomization,
- •except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for
- •4.Any of the following within the 12 months prior to study drug administration:
- •severe/unstable angina, myocardial infarction, coronary artery bypass graft,
- •symptomatic congestive heart failure, cerebrovascular accident, including transient
- •ischemic attack, or pulmonary embolism.
- •5. Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or
- •dosing before 7 and 12 days before date of randomization (e.g., ketoconazole,
- •rifampin, etc. respectively).
- •6. Ongoing cardiac dysrhythmias of NCI CTCAE grade >/= 2, atrial fibrillation of any
- •grade, or prolongation of the QTc interval to > 500 msec.
- •7.Hypertension that cannot be controlled by medications.
- •8.Treatment with anticoagulant agents and treatment with therapeutic doses of warfarin
- •currently or within 2 weeks prior to first day of sunitinib administration. Low dose
- •warfarin for deep vein thrombosis (DVT) prophylaxis is permitted (up to 2 mg/day).
- •Low molecular weight heparin or aspirin are allowed.
- •9.Inability to swallow oral medications, or presence of active inflammatory bowel
- •disease, partial or complete bowel obstruction or chronic diarrhea.
- •10. Known human immunodeficiency virus (HIV) or acquired immunodeficiency
- •syndrome (AIDS)-related illness.
- •11.Known active hepatitis.
- •12.Pregnancy or breastfeeding. All female subjects with reproductive potential must
- •have a negative pregnancy test (serum or urine) within the 7 days prior to date of randomization.
- •13.Other severe acute or chronic medical or psychiatric condition or laboratory
- •abnormality that may increase the risk associated with study participation or study
- •drug administration, or may interfere with the interpretation of study results, and in
- •the judgment of the investigator would make the subject inappropriate for entry into this study.
- •14.Receipt of any investigational oncology or, approved or investigational antiangiogenic
- •agent prior to study entry.
- •15.Current treatment on another therapeutic clinical trial. Supportive care trials or nontreatment
- •trials, e.g. PRO methods studies, are allowed.
研究者
相似试验
进行中（未招募）
1 期
Phase 3 study of sunitinib versus placebo in subjects at high risk of recurrent kindey cancerAdjuvant treatment of subjects with high risk” Renal Cell Carcinoma (RCC) following nephrectomy.MedDRA version: 11.0Level: HLTClassification code 10038408Term: Renal cell carcinomasSystem Organ Class: 100000005104EUCTR2006-004024-37-SKPfizer Inc.619
进行中（未招募）
1 期
Phase 3 study of sunitinib versus placebo in subjects at high risk of recurrent kidney cancerAdjuvant treatment of subjects with high risk” Renal Cell Carcinoma (RCC) following nephrectomy.MedDRA version: 11.0Level: HLTClassification code 10038408Term: Renal cell carcinomasSystem Organ Class: 100000004864EUCTR2006-004024-37-IEPfizer Inc. 235 East 42nd Street, New York, 10017619
进行中（未招募）
1 期
Phase 3 study of sunitinib versus placebo in subjects at high risk of recurrent kidney cancerEUCTR2006-004024-37-GBPfizer Inc. 235 East 42nd Street, New York, 10017615
进行中（未招募）
1 期
Phase 3 study of sunitinib versus placebo in subjects at high risk of recurrent kindey cancerEUCTR2006-004024-37-PLPfizer Inc. 235 East 42nd Street, New York, 10017619
进行中（未招募）
1 期
Phase 3 study of sunitinib versus placebo in subjects at high risk of recurrent kindey cancerEUCTR2006-004024-37-SEPfizer Inc.619