EUCTR2008-003196-48-FR进行中（未招募）不适用
A phase II - III double-blind study of oral vinflunine plus best supportive care versus placebo plus best supportive care in patients with malignant pleural mesothelioma previously treated with systemic chemotherapy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 396
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 proven diagnosis of malignant pleural mesothelioma.
- •2. Only one prior systemic chemotherapy regimen that included pemetrexed with a platinum analogue. A minimum interval of 4 weeks should have elapsed between the last administration of chemotherapy and study entry
- •3. Documented progressive disease that occurs during or after first-line chemotherapy. Patients must have received at least 2 cycles of first-line chemotherapy.
- •4. Presence of at least one measurable target lesion according to modified RECIST.
- •5. Male or female at least 18 years of age
- •6. Performance status 0, 1 or 2
- •7. No radiotherapy for 3 weeks ; at least 2 weeks for pleurodesis, targeted therapy and immunotherapy
- •8. Adequate bone marrow function defined as :
- •- Haemoglobin >or=10 g/dL
- •- Absolute neutrophil count >1.5 x 10 9/L
- •- Platelet count >100 x 10 9/L
- •9. Adequate liver function tests defined as total bilirubin 10. Serum creatinine < ULN and creatinine clearance >or= 50 mL/min according to Cockroft and Gault formula.
- •11. Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimized. Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the start of study treatment
- •12. Fertile men must be using an effective method of birth control if their partners are women of childbearing potential
- •13. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial
- •14. The patient must give written (personally signed and dated) informed consent before completing any study-related procedure which means assessment or evaluation that would not form part of the normal medical care of the patient
- •15. Ability to swallow capsules
- •16. The patient must have access to a social insurance according to local regulations.
- •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. A female is not eligible to enter the study if :
- •- Pregnant or lactating
- •- With positive pregnancy test at inclusion
- •2. Male or female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and at least 3 months following the last dose of study treatment
- •3. Known hypersensitivity to the study drug or to drugs with similar chemical structures
- •4. History of CNS metastases, unless the patient has been previously treated for CNS metastases, is stable for at least 4 weeks by CT scan without evidence of cerebral oedema, and has no requirement for corticosteroids or anticonvulsivants
- •5. Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled i.e active serious infection, diabetes mellitus, concurrent heart failure [New York Heart Association (NYHA) class III-IV] or with progressive or unstable angina, myocardial infarction within 6 months, and/or poorly controlled hypertension, or pericardial effusion
- •6. History of significant neurologic or psychiatric disorders, precluding understanding and giving of informed consent
- •7. History of other cancers with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated with surgery and/or radiotherapy and with no evidence of disease for at least 5 years
- •8. Grade = 2 peripheral neuropathy at study entry according to NCI-CTC AE (version 3.0)
- •9. Prior extensive radiotherapy up to more than 25% of bone marrow reserve
- •10. Prior treatment with a vinca alkaloid
- •11. Patients with grade = 2 dysphagia;
- •12. Participation into a clinical study of an investigational agent within 28 days before study entry
- •13. Concurrent treatment with any other anti-cancer therapy except bisphosphonates
- •14. Any alteration of gastro-intestinal tract likely to impact on absorption and elimination of oral drugs like:
- •- malabsorption syndrome
- •- extensive surgery of the stomach or the small bowel
- •- major alterations of gastro intestinal transit such as subocclusive syndrome whatever the aetiology.
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