CTRI/2010/091/000026招募中3 期
A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
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
入选标准
- •1. Greater and equal to 18-years of age.
- •2. Subjects with recurrent or metastatic RCC.
- •3. Subjects must have undergone prior nephrectomy (complete or partial) for excision of the primary tumor.
- •4. Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, mixed tumor containing predominantly sarcomatoid cells, and unclassified RCC are excluded).
- •5. Measurable disease per the RECIST criteria Version 1.0 (see Appendix A). Measurable disease must be verified by an independent radiologist prior to randomization.
- •6. Treatment naïve subjects or subjects who have received no more than one prior systemic treatment (immunotherapy, including interferon-alfa or interleukin-2 based therapy, chemotherapy, hormonal therapy or an investigational agent) for metastatic RCC. Postoperative or adjuvant systemic therapy will not be counted as a prior therapy unless recurrence is detected within 6 months of completion of treatment, in which case it will be counted as a prior therapy for metastatic disease.
- •7. ECOG performance status of 0 or 1, and life expectancy greater and equal to3 months (see Appendix B).
- •8. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
- •9. Ability to give written informed consent and comply with protocol requirements.
排除标准
- •1. Any prior VEGF-directed therapy including VEGF antibody (eg, bevacizumab), VEGF receptor tyrosine kinase inhibitor (eg, sunitinib, sorafenib, axitinib, pazopanib, etc.), VEGF trap (eg, aflibercept), or any other agent or investigational agent targeting the VEGF pathway.
- •2. Any prior therapy with an agent targeting the mTOR pathway (eg, temsirolimus, everolimus, etc)
- •3. Primary CNS malignancies or symptomatic CNS metastases; subjects with previously treated brain metastasis will be allowed if the brain metastasis have been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
- •4. Any of the following hematologic abnormalities:
- •Hemoglobin < 9.0 g/dL
- •ANC < 1500 per mm3
- •Platelet count < 100,000 per mm3
- •PT or PTT >1.5 × ULN
- •5. Any of the following serum chemistry abnormalities:
- •Total bilirubin > 1.5 × ULN (or > 2.5 × ULN for subjects with Gilbert's syndrome)
- •AST or ALT > 2.5 × ULN (or > 5 × ULN for subjects with liver metastasis)
- •Alkaline phosphatase > 2.5 × ULN (or > 5 × ULN for subjects with liver or bone metastasis)
- •Creatinine > 2.0 × ULN
- •Proteinuria > 3+ by urinalysis or urine dipstick
- •6. Significant cardiovascular disease, including:
- •Active clinically symptomatic left ventricular failure.
- •Uncontrolled hypertension: Systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 24 hours apart.
- •Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug.
- •History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation)
- •Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication)
- •7. Non-healing wound, bone fracture, or skin ulcer.
- •8. Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
- •9. Serious/active infection or infection requiring parenteral antibiotics.
- •10. Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
- •11. Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:
- •Deep vein thrombosis
- •Pulmonary embolism
- •Cerebrovascular accident (CVA) or transient ischemic attach (TIA)
- •Peripheral arterial ischemia > Grade 2
- •Coronary or peripheral artery bypass graft.
- •12. Significant bleeding disorders within 6 months prior to administration of first dose of study drug, including but not limited to.
- •Hematemesis, hematochezia, melena or other gastrointestinal bleeding Grade 2
- •Hemoptysis or other pulmonary bleeding Grade 2
- •Hematuria or other genitourinary bleeding Grade 2
- •13. Currently active second primary malignancy, including hematologic malignancies (leukemia, lymphoma, multiple myeloma, etc.), other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer and ductal or lobular c
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