KCT0003447已完成未知
A Phase II trial of Pazopanib and Durvalumab for Metastatic Soft Tissue Sarcoma
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Histologically confirmed soft tissue sarcoma progression to 1 or 2 prior chemotherapy
- •2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •3. Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
- •4. Body weight = 30kg
- •5. Adequate normal organ and marrow function as defined below:
- •? Haemoglobin =9.0 g/dL
- •? Absolute neutrophil count (ANC) > 1500 per mm3
- •? Platelet count = 75,000 per mm3
- •? Serum bilirubin =1.5 x institutional upper limit of normal (ULN).
- •? AST (SGOT)/ALT (SGPT) =2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =5x ULN
- •? Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance (CL)>40 mL/min by the Cockcroft-Gault formula.
- •6. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply
- •7. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- •8. Must have a life expectancy of at least 12 weeks
- •9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •10. Patients with evidence of portal hypertension (including splenomegaly detected radiographically) or any prior history of variceal bleeding must have had endoscopic evaluation within the 3 months immediately prior to enrollment, and the findings do not represent a high bleeding risk.
排除标准
- •1. More than 4 prior cytotoxic regimens
- •2. Participation in another clinical study with an investigational product during the last 2 weeks
- •3. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 14 days prior to the first dose of study drug
- •4. Any previous treatment with a PD1 or PD-L1 inhibitor (including durvalumab) and/or pazopanib
- •5. Mean QT interval corrected for heart rate (QTc) > 480 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction
- •6. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •7. Any concurrent chemotherapy, biologic, or hormonal therapy for cancer treatment within 14 days prior to entering the study.
- •8. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 14 days of the first dose of study drug
- •9. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- •10. History of allogenic organ transplantation.
- •11. Active or prior documented autoimmune or inflammatory disorders.
- •12. Uncontrolled intercurrent illness.
- •13. Known active infection
- •14. History of another primary malignancy.
- •15. History of leptomeningeal carcinomatosis who are neurologically unstable or have required active treatment
- •16. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- •17. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose.
- •18. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- •19. No history of any of the following in the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease class III or IV congestive heart failure, as defined by the New York Heart Association), thromboembolic events (patients who were stable, taking anticoagulation drugs for = 6 weeks are eligible)
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