EUCTR2006-004956-19-BG进行中（未招募）不适用
A randomized, open-label, multi-center, phase II/III study on treatment with ABR-217620 combined with IFN-a vs. IFN-a alone in patients with advanced renal cell carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 524
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.Histologically or cytologically confirmed renal cell carcinoma (clear cell and papillary types). Biopsy of a metastasis is permitted if the primary tumor is inapproachable.
- •2.Metastatic or inoperable locally advanced renal cell cancer.
- •3.Patient must be eligible for therapy with IFN-a.
- •4.Measurable disease defined by the presence of at least one measurable lesion documented on CT scan (lesion diameter = 2.0 cm measured by a standard (conventional) CT scanner or = 1.0 cm measured by a spiral CT scanner).
- •5.Favorable or moderate risk group prognosis by MSKCC (Motzer) criteria (score 0-2).
- •6.Karnofsky performance status = 70.
- •7.Age = 18 years.
- •8.Life expectancy > 3 months.
- •9.Patient has the following blood counts at baseline:
- •absolute neutrophil count (ANC) = 1.5 x 109/L
- •platelets = 100 x 109/L
- •haemoglobin = 100 g/L
- •10.Patient has the following blood chemistry levels at baseline:
- •creatinine = 1.5 × upper limit of normal
- •bilirubin = 2 × upper limit of normal
- •aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × upper limit of normal. AST and ALT allowed = 5 × upper limit of normal for patients with liver metastases.
- •11.If fertile, the patient agrees to use an effective method of contraception from the screening visit through the duration of study participation (barrier method for males; hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence for females).
- •12.The patient is willing and able to comply with the treatment and scheduled follow-up visits and examinations.
- •13.Patient is capable of understanding the parameters outlined in the protocol and able to sign a written informed consent form.
- •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 424
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1.Pregnant or breast-feeding women are prohibited to take part in the study.
- •2.A serious uncontrolled medical disorder or active infection which are either ongoing or have resolved within 2 weeks before the first dose of the study treatment and which in the opinion of the investigator would impair the patient’s ability to receive the study treatment.
- •3.History of any malignancy within the past 5 years or any concurrent malignancy, with the exception of the following malignancies, which may still be included if successfully treated: non-melanoma skin cancer, cervical cancer in situ, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) of breast.
- •4.History and/or signs of parenchymal brain metastases.
- •5.Significant cardiac disease including: history (within the past 6 months) or current unstable angina pectoris, congestive heart failure of stage III-IV (NYHA), or myocardial infarction within the past 12 months; or patients with uncontrolled arterial hypertension.
- •6.History of a stroke within the past 5 years and/or transient ischemic attack within the past 6 months.
- •7.Acute illness or evidence of infection, including unexplained fever (body temperature > 100.5 degrees F or 38.1degrees C) within 2 weeks prior to start of treatment.
- •8.Treatment with beta-blockers, excluding topical therapy for glaucoma, within 5 days prior to the start of the study treatment and during the 4 day ABR-217620 treatment period.
- •9.Treatment with systemic corticosteroids within 2 weeks prior to the start of treatment or the patient will likely require such treatment throughout the study.
- •10.Active autoimmune disease requiring therapy or any history of systemic lupus erythematosis or rheumatoid arthritis.
- •11.Treatment with biological response modifiers within 3 weeks of the first dose of the investigational products and up to the End-of-Study visit.
- •12.Known positive serology for HIV (patients with a known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in the immunocompromised host).
- •13.Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic virus hepatitis or the known virus carrying. Patients who recovered from Hepatitis A are allowed to enter the study.
- •14.Treatment with anticoagulants within 2 weeks prior to the start of treatment, except when used to maintain the patency of a central or peripheral venous line. If a patient requires anticoagulants, his eligibility should be discussed with the Medical Monitor prior to enrollment.
- •15.Radiotherapy less than 4 weeks before the start of treatment. The patient should fully recover from the side effects of radiotherapy to start the study treatment.
- •16.Major surgery or tumor embolization less than 4 weeks before the start of treatment. The patient should fully recover after the surgery to start the study treatment.
- •17.Previous history of exposure to murine monoclonal antibodies or known hypersensitivity to murine proteins.
- •18.Patients currently on renal dialysis treatment.
- •19.Known allergy or hypersensitivity to aminoglycosides and kanamycin.
- •20.Previous systemic anti-tumor therapy for RCC (including immunotherapy with IFN-a or IL-2 or any chemotherapy) with the exception of sunitinib or other oral antiangiogenic therapy.
- •21.Participation in any other study involving investigational drugs for treatment of RCC within the last 6 weeks. The patients must not partic
研究者
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