EUCTR2008-006068-12-DE进行中（未招募）不适用
A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of ZD4054 plus Carboplatin and Paclitaxel or Placebo plus Carboplatin and Paclitaxel in Patients with Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 122
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. Provision of informed consent prior to any study specific procedures
- •2. Females aged 18 years and older
- •3. Histologically proven diagnosis of:
- •- Epithelial ovarian carcinoma
- •- Fallopian tube carcinoma
- •- Primary serous peritoneal carcinoma
- •4. Advanced disease not amenable to curative surgery or radiotherapy at the time of study entry with evidence of disease recurrence or progression at least 6 months following treatment cessation of first-line platinum-containing therapy and having stopped any maintenance therapy at least 30 days prior first dose of treatment with study drug (if applicable, excluding platinum-based maintenance therapy).
- •5. Radiologically documented measurable disease according to RECIST criteria
- •assessed by Computerised Tomography (CT) or Magnetic Resonance Imaging
- •(MRI) or radiologically documented non-measurable (but evaluable) disease. A
- •non-measurable but evaluable patient is defined as a patient with a non-measurable
- •soft tissue lesion (this includes bone lesions) that can be determined according to
- •RECIST and documented via a CT or MRI scan. Patients with ascites and/or
- •pleural/pericardial effusion only, are not considered as evaluable in this study
- •6. World Health Organisation (WHO) performance status 0 to 2
- •7. Estimated life expectancy of more than 16 weeks
- •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
- •Clinical evidence of central nervous system (CNS) metastases
- •2. Non-epithelial ovarian cancer, including malignant mixed Mullerian tumours and
- •mucinous carcinoma of the peritoneum
- •3. Tumour of borderline malignancy
- •4. A second primary malignancy (except in situ carcinoma of the cervix or adequately
- •treated basal cell carcinoma of the skin) in the last 5 years
- •5. Inadequate bone marrow reserve as demonstrated either by an absolute neutrophil
- •count <1.5 x 109/L or platelet count <100 x 109/L
- •6. Haemoglobin =9 g/dL (5.59 mMol/L)
- •7. Stage II, III or IV cardiac failure (classified according to New York Heart
- •Association [NYHA] classification [see Appendix D]) or myocardial infarction
- •within 6 months prior to study entry
- •8. Severe or frequent migrainous headaches
研究者
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