EUCTR2006-004822-97-GB进行中（未招募）1 期
A Phase I / II Trial to Evaluate the Combination of Infliximab and Sorafenib in the Treatment of Renal Cell Carcinoma - Combination Infliximab and Sorafenib in RCC
The Royal Marsden NHSF Trust0 个研究点目标入组 51 人开始时间: 2009年5月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
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. Patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
- •2. The presence of one or more clinically or radiologically measurable lesions
- •3. ECOG performance status 0 or 1
- •4. Life expectancy greater than 12 weeks
- •5. At least 21 days since major surgery and 7 days since skin/tumour biopsy
- •6. The capacity to understand the patient information sheet and the ability to provide written informed consent
- •7. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •8. Male or female, age 18 or greater
- •9. Women must be postmenopausal (no menstrual period for a minimum of 1 year) or have a negative serum pregnancy test on entry in the study (even if surgically sterilized). Men and women of childbearing potential must use adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last study treatment
- •10. Serum aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 x upper limit of normal (ULN)
- •11. Total serum bilirubin =1.5 x ULN
- •12. Serum creatinine =1.5 x ULN
- •13. Haemoglobin =9.0 g/dL
- •14. Absolute neutrophil count =1.5 x 109/L
- •15. Platelets =100 x 109/L
- •16. Prothrombin time (PT) =1.5 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 treatment with monoclonal antibodies or antibody fragments, or known hypersensitivity to any murine proteins or other infliximab components
- •2. Known infection with human immunodeficiency virus (HIV) and / or hepatitis B surface antigen or hepatitis C
- •3. Known history of serious infections (e.g. hepatitis, pneumonia or pyelonephritis) in the previous 3 months
- •4. Opportunistic infections (e.g. herpes zoster (shingles), cytomegalovirus, active pneumocystis carinii, aspergillosis, histoplasmosis, or atypical mycobacteria infection other than TB) within the last 6 months
- •5. History of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g. nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area) or splenomegaly#
- •6. Current signs or symptoms of severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, pulmonary or cardiac disease other than directly related to RCC
- •7. Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days
- •8. Previous treatment with a tyrosine kinase inhbitor or anti-angiogenic agent (licensed or investigational) such as sunitinib or bevacizumab
- •9. Any drug (licensed or investigational) that targets the RAS or EGFR pathway
- •10. Any chemotherapy, immunotherapy or hormonal treatment over the last 4 weeks. Palliative radiotherapy to symptomatic disease sites is permitted
- •11. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment)
- •12. Chest radiograph at screening that shows evidence of malignancy, infection, or any abnormalities suggestive of TB as described in Appendix C
- •13. Ineligibility according to the TB eligibility assessment, screening, and early detection of reactivation rules (see Appendix C)
- •14. Malignancy other that the condition being treated or a history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence
- •15. Use of any investigational drug within 30 days prior to screening or within 50 days of infliximab infusion
- •16. Presence of a transplanted solid organ (with the exception of a corneal transplant) > 3 months prior to screening
- •17. History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
- •18. Peripheral neuropathy greater than grade 1 according to the Common Terminology Criteria (CTC) criteria
- •19. Concomitant diagnosis or history of congestive heart failure as assessed by the investigator
- •20. Uncontrolled hypertension or hypertension treated with 2 or more anti-hypertensive agents
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