EUCTR2008-002156-14-PL进行中（未招募）不适用
A phase II non-randomised, open-label, single-arm study to assess the efficacy, safety and tolerability of Nexavar ® (Sorafenib) monotherapy as third line therapy in patients with progressed ovarian epithelial or primary peritoneal cancer. - OCCASIONE
FUNDATION OF EXPERIMENTAL AND CLINICAL ONCOLOGY0 个研究点开始时间: 2008年7月16日最近更新:
适应症
相关药物
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
- Female
入选标准
- •1. Female patient = 18 years old.
- •2. Histologically or cytologically confirmed ovarian epithelial or primary peritoneal cancer.
- •3. Recurrent or refractory disease.
- •4. Prior chemotherapy regimens (e.g., initial chemotherapy platinum-based and 1 regimen for subsequent relapse or due to resistance for initial CHT). Each subject must receive regimen based on platinum analogs (carboplatin AUC 5-6 or cisplatin 75 mg/ m2) and paclitaxel based regimen. It could be patients with refractory ovarian cancer (< 6 months to relapse or progression or without any clinical response) or sensitive (> 6 months), the prior chemotherapy must be finished at least 4 weeks before starting of sorafenib treatment.
- •6. If measurable disease is in a previously irradiated site, there must be disease progression in that lesion 6 months after completion of radiotherapy.
- •7. ECOG performance status 0 – 2.
- •8. Female patients must be using effective contraception, be surgically sterile or be postmenopausal. All at-risk female patients must have a negative serum pregnancy test within 7 days prior to study drug administration.
- •9. Patients with adequate bone marrow, liver and renal function.
- •10. Signed informed consent must be obtained 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
- •1. Known or suspected allergy to the investigational agent or any agent given in association with the trial.
- •2. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta,Tis,T1) or any cancer curatively treated >3 years prior to study entry.
- •3. History of cardiac disease.
- •4. History of HIV infection or chronic hepatitis B or C.
- •5. Active clinically serious infections.
- •6. Symptomatic metastatic brain ot meningeal tumors
- •7. Seizure disorders requiring medications.
- •8. History of organ allograft or patients undergoing renal dialysis
- •9. Thrombotic or embolic events.
- •10.Pregnant or breast-feeding patients.
研究者
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