EUCTR2006-004956-19-GB进行中（未招募）1 期
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. Protocol Version 1 dated 2006-10-06. Protocol Version 2 including Protocol Amendment 1 dated 2007-05-10. Protocol Version 3 including Protocol Amendment 2 dated 2007-11-07. Protocol Version 4 including Protocol Amendment 3 dated 2008-05-29.
适应症
试验速览
- 阶段
- 1 期
- 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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. Symptomatic treatment with hormonal therapy (e.g. megestrol, medroxyprogesteron or tamoxifen) is allowed as it is not to be regarded as systemic anti-tumor therapy
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