EUCTR2005-005024-14-HU进行中（未招募）1 期
A multicenter, randomized, double-blind, parallel-arm, two-stage study of the efficacy and safety of AVE0005 (VEGF Trap) administered intravenously every 2 weeks in patients with platinum-resistant and topotecan- and/or liposomal doxorubicin-resistant advanced ovarian cancer
Sanofi-Synthélabo Recherche, a subsidiary of sanofi-aventis group0 个研究点目标入组 200 人开始时间: 2006年4月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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. Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma.
- •2. Prior treatment with at least 2 treatment regimens in the advanced disease treatment setting.
- •3. Platinum-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
- •4. Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
- •5. Evidence of at least one unidimensionally measurable tumor lesion by CT or MRI scan according to Response Evaluation Criteria in Solid Tumors (RECIST) that has not been treated with surgery or radiation therapy.
- •6. Female, 18 years of age or older.
- •7. ECOG performance status =2.
- •8. Resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE v.3.0 grade =1 and to baseline laboratory values as defined in inclusion criterion #9.
- •9. Adequate organ and bone marrow function as evidenced by:
- •a. hemoglobin =9.0 g/dL
- •b. absolute neutrophil count =1.5 x 10 9 /L
- •c. platelet count =75 x 10 9 /L
- •d. creatinine =1.5 x ULN, and either proteinuria =500 mg/24 hours or urine
- •protein:creatinine ratio (UPCR) =1
- •e. AST/SGOT and ALT/SGPT =2.5 x ULN
- •f. total bilirubin =1.5 x ULN
- •10. Patients must be postmenopausal, surgically sterile, or using effective contraception. All patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment.
- •11. Patients must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Informed consent must be obtained in writing for all patients prior to enrollment into the study.
- •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. Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri.
- •2. More than 3 chemotherapy regimens in the advanced disease treatment setting.
- •3. Prior treatment with a VEGF or VEGF receptor inhibitor.
- •4. Anticipation of a need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the study.
- •5. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical trial protocol.
- •6. History of hypersensitivity to any Trap agents or recombinant proteins.
- •7. Treatment with chemotherapy, radiotherapy, surgery, blood products, or an investigational agent within 3 weeks (6 weeks for nitrosoureas, mitomycin C, immunotherapy, or major surgery) of study enrollment.
- •8. Uncontrolled hypertension, defined as blood pressure >150/100 mm Hg (NCI CTCAE v.3.0 grade =2), or systolic blood pressure >180 mm Hg if diastolic blood pressure <90 mm Hg, on at least 2 repeated determinations on separate days within 3 months prior to study enrollment.
- •9. Any of the following within 6 months prior to study enrollment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, grade =2 peripheral neuropathy, peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, deep vein thrombosis, or other thromboembolic event.
- •10. History of brain metastases, spinal cord compression, or carcinomatous meningitis.
- •11. Evidence of clinically significant bleeding diathesis including hemoptysis, or underlying coagulopathy.
- •12. Active infection, or on antiretroviral therapy for HIV disease.
- •13. Patient is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- •14. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
- •15. Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- •16. Refusal or inability to give informed consent to participate in the study.
- •17. Pregnancy or breastfeeding.
- •18. Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient’s safety, inhibit protocol participation, or interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- •19. Patient has been previously randomized in this study.
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