EUCTR2006-001014-32-IT进行中（未招募）不适用
PHASE II STUDY OF BAY 43-9006 IN PATIENTS WITH ADVANCEDCHOLANGIOCELLULAR CARCINOMA - SORACCC
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 个研究点开始时间: 2007年7月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •?Age ?18 years.
- •?Patients should have proven primary CCC according to one of the following criteria:
- •oHistological evidence of CCC on a biopsy specimen.
- •oECOG Performance Status of 0 or 1 (see appendix 8.4).
- •?Patients with at least one measurable lesion by CT-scan or MRI according to the RECIST criteria, performed within 4 weeks prior to start of dosing.
- •?Patients who have received systemic 1st or 2nd line chemotherapy
- •?Patients who have received local therapy, such as: surgery, radiation therapy, hepatic arterial embolization, chemo-embolization, radio-frequency ablation or cryo-ablation are eligible, provided that they either have a target lesion which has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ?25% in the size. Furthermore, the local therapy applied to target or non-target lesions needs to have been completed at least 8 weeks prior to study inclusion (Lesions treated with external beam radiation therapy are not acceptable as target lesions, unless they fulfill the conditions described above).
- •?Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •oHemoglobin ? 8.5 g/dl
- •oAbsolute granulocytes ? 1.5 x 109/L
- •o Platelet count ? 60 x 109/L
- •oTotal serum bilirubin ? 3 mg/dl
- •oALT (SGOT) and AST (SGPT) ? 5 x upper limit of normal
- •oPT-INR? 2.3 or PT ? 6 seconds above control
- •oSerum creatinine ? 1.5 x upper limit of normal.
- •?Written Informed Consent must be obtained and documented prior to any study specific procedures.
- •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
- •?Congestive heart failure defined as NYHA class III or IV.
- •?Serious cardiac arrhythmias.
- •?Active coronary artery disease or ischemia.
- •?Active clinically serious infections (> grade 2 NCI-CTC).
- •?Known history of HIV infection.
- •?Known metastatic brain or meningeal tumors.
- •?History of seizure disorder.
- •?History of organ allograft.
- •?Previous malignancy (except for cervical carcinoma in situ, adequately treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis & T1] or other malignancies curatively treated > 3 years prior to entry).
- •?Patients with clinically significant gastrointestinal bleeding within the past month prior to study entry are ineligible.
研究者
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