EUCTR2009-012570-13-ES进行中（未招募）不适用
Estudio fase II de seguridad, abierto, no controlado, multicéntrico con BAY 73-4506 en pacientes con carcinoma hepatocelular (HCC) (An uncontrolled open label multicenter phase II safety study of BAY 73-4506 in patients with hepatocellular carcinoma (HCC))
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- •*Male or female patients aged equal or above18 years.
- •*Histological or cytological confirmation of HCC or non-invasive diagnosis of HCC as per AASLD criteria.
- •*BCLC stage Category A, B or C that cannot benefit from treatments of established efficacy with higher priority such as resection, liver transplantation, local ablation, chemoembolization or systemic sorafenib.
- •*Liver function status Child-Pugh class A.
- •*Failure to prior treatment with sorafenib (defined as radiological progression under sorafenib therapy)
- •*Local or loco-regional therapy (eg, surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ? 4 weeks before first dose of BAY 73-4506.
- •*Recovery from any previous drug/procedure-related toxicity to CTC Grade 0 or 1 levels (except alopecia), or to baseline preceding the prior treatment.
- •*ECOG PS of 0 or 1.
- •*Adequate bone marrow, liver and renal function as assessed by the following laboratory tests conducted (Modified diet in renal disease) abbreviated formula
- •*At least one naïve (not previously treated by locoregional therapy) uni-dimensional measurable lesion by computed tomography [CT] scan or magnetic resonance imaging [MRI] according to Response Evaluation Criteria (RECIST) and JNCI amendments regarding characterization of lesions in HCC
- •*Life expectancy of at least 3 months.
- •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
- •*Prior treatment with BAY 73-4506.
- •*Large esophageal varices at risk of bleeding that are not being treated with conventional medical intervention: beta blockers or endoscopic treatment. Assessment of esophageal varices should be performed by endoscopy within 6 months of study start, and within 12 months for patients in whom conventional medical intervention for known esophageal varices is already in place.
- •*Prior systemic treatment with molecular targeted agents for HCC, except sorafenib. Prior chemotherapy treatment is allowed.
- •*Past or concurrent history of neoplasm other than HCC, except for in situ carcinoma of the cervix uteri and/or basal cell epithelioma. Any cancer curatively treated > 5 years prior to study entry is permitted.
- •*Known history or symptomatic metastatic brain or meningeal tumors (head CT or MRI at screening to confirm the absence of central nervous system [CNS] disease if patient has symptoms suggestive or consistent with CNS disease).
- •*Major surgical procedure or significant traumatic injury within 28 days before start of study medication.
- •*Pregnant or breast-feeding patients.
- •*Congestive heart failure NYHA>= class 2
- •*Unstable angina (angina symptoms at rest, new ?onset angina ie, within the last 3 months) or myocardial infarction (MI) within the past 6 months before start of study medication.
- •*Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •*Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- •*Patients with phaeochromocytoma.
- •*Ongoing infection > Grade 2 NCI-CTC version 3.0.
- •*Persistent proteinuria of CTC Grade 3 or higher (> 3.5 g/24 hours, measured by urine protein/creatinine ratio on a random urine sample).
- •*Clinically significant bleeding within 30 days before start of study medication.
- •*Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months before the start of study treatment.
- •*Dehydration NCI-CTC version 3.0 Grade ? 1.
- •*Unresolved toxicity higher than NCI-CTCAE (version 3.0) Grade 1 (excluding alopecia) attributed to any prior therapy/procedure.
- •*Any illness or medical condition that is unstable or could jeopardize the safety of the patient and his/her compliance in the study.
- •*Known history of human immunodeficiency virus (HIV) infection.
- •*Patients with seizure disorder requiring medication.
- •*History of organ allograft.
- •*Non-healing wound, ulcer, or bone fracture.
- •*Renal failure requiring hemo-or peritoneal dialysis.
- •*Substance abuse, medical, psychological or social conditions that may interfere with the patient?s participation in the study or evaluation of the study results.
- •*Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
- •*Patients unable to swallow oral medications.
- •*Interstitial lung disease with ongoing signs and symptoms at the time of screening.
- •*Any malabsorption condition.
研究者
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