EUCTR2009-011400-33-ES进行中（未招募）不适用
Ensayo fase III multicéntrico, abierto, aleatorizado, de dos brazos, de bevacizumab más quimioterapia versus quimioterapia sola para el tratamiento de pacientes con cáncer de ovario epitelial, de trompa de Falopio o peritoneal primario, resistente a platinos. A multi-centre, open-label, randomised, two-arm Phase III trial of bevacizumab plus chemotherapy versus chemotherapy alone in patients with platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer. - AURELIA
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
- 300
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. Signed informed consent obtained prior to initiation of any study-specific
- •procedures and treatment as confirmation of the patient?s awareness and
- •willingness to comply with the study requirements.
- •2. Patients greater than or equal to 18 years of age with histologically confirmed and
- •documented. The following histological types are eligible:
- •? adenocarcinoma NOS
- •? clear cell adenocarcinoma
- •? endometriod adenocarcinoma
- •? malignant Brenner's tumour
- •? mixed epithelial carcinoma
- •? mucinous adenocarcinoma
- •? serous adenocarcinoma
- •? transitional cell carcinoma
- •? undifferentiated carcinoma.
- •3. Patients must have platinum-resistant disease, (defined as progression within <6
- •months of platinum therapy)
- •4. Patients must have disease that is measurable according to RECIST or assessable
- •according to the GCIG CA-125 criteria and require chemotherapy treatment.
- •5. ECOG PS 0?2.
- •6. Life expectancy of greater than or equal to 12 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
- •1. Patients whose disease was refractory to their previous treatment.
- •2. Non-epithelial, including malignant mixed Müllerian tumours.
- •3. Ovarian tumours with low malignant potential.
- •4. Other malignancy within the last 5 years
- •5. Previous treatment with >2 chemotherapy regimens.
- •6. Any prior radiotherapy to the pelvis or abdomen.
- •7. Surgery (incl. open biopsy) within 4 weeks prior to the start of study, or
- •anticipation of the need for major surgery during study treatment.
- •8. Minor surgical procedures within 24 hours prior to first study treatment.
- •9. Previous exposure to murine CA-125 Ab (only applicable to those patients
- •with non-measurable disease by RECIST).
- •10. Current or recent chronic daily treatment with aspirin (>325 mg/day).
- •11. Current or recent treatment with another investigational drug and/or
- •participation in another investigational study within 30 days of first study
- •treatment dosing or earlier participation in this study.
- •12. Chronic daily treatment with corticosteroids, excluding inhaled steroids.
- •13. Inadequate bone marrow function: ANC: <1.5 x 10E9/l, or platelet count <100 x
- •10E9/l, or haemoglobin <9 g/dl. Patients may be transfused to maintain
- •haemoglobin values >9 g/dl.
- •14. Inadequate coagulation parameters: aPTT >1.5 x ULN (patients on heparin
- •treatment must have an aPTT between 1.5 - 2.5 x ULN), or INR >1.5.
- •15. Inadequate liver function, defined as: serum (total) bilirubin >1.5 x ULN for the
- •institution; alkaline phosphatase, AST/SGOT or ALT/SGPT >2.5 x ULN (or 5 x ULN
- •in the presence of liver metastases).
- •16. Inadequate renal function, defined as serum creatinine >2.0 mg/dl or >177
- •µmol/l or calculated creatinine clearance <40ml/min for patients intended to be
- •treated with topotecan. urine dipstick for proteinuria >2+. Patients with greater
- •than or equal to 2+ proteinuria on baseline dipstick analysis should undergo
- •a 24-hour urine collection and must demonstrate ?1 g of protein in the 24-hour
- •urine. Alternatively, proteinuria testing can be performed according to local
- •17. History or evidence upon physical/neurological examination of CNS disease
- •unrelated to cancer, unless adequately treated with standard medical therapy
- •(e.g. uncontrolled seizures).
- •18. Symptomatic CNS metastasis
- •19. Pre-existing peripheral neuropathy ?CTC grade 2.
- •20. Pregnant or lactating females. Serum pregnancy test to be assessed within 7
- •days prior to study treatment start, or within 14 days (with a confirmatory urine
- •pregnancy test within 7 days prior to study treatment start).
- •21. Women of childbearing potential not using highly-effective, non-hormonal means
- •of contraception (intrauterine contraceptive device or barrier method of
- •contraception in conjunction with spermicidal jelly) during the study and for 6
- •months after the last dose of study medication.
- •22. History or evidence of thrombotic or hemorrhagic disorders; including CVA/
- •stroke or TIA or sub-arachnoid haemorrhage within ?6 months prior to the first
- •study treatment.
- •23. Uncontrolled hypertension (sustained systolic >150 mmHg and/or diastolic >100
- •mmHg despite antihypertensive therapy) or clinically significant (i.e. active)
- •cardiovascular disease, including: myocardial infarction or unstable angina within
- •?6 months prior to the first study treatment; NYHA grade II or greater
研究者
相似试验
进行中（未招募）
1 期
Ensayo en fase 3, multicéntrico, abierto, aleatorizado y controlado de 24 semanas para comparar la eficacia y la seguridad de la inhalación prandial de Technosphere®/Insulina en combinación con metformina o Technosphere®/Insulina en monoterapia frente a dos antidiabéticos orales (metformina y un secretagogo) en sujetos con diabetes mellitus tipo 2 controlada de forma subóptima con la combinación de metformina y un secretagogoA Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere®/Insulin in Combination with Metformin or Technosphere®/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-Optimally Controlled on Combination Metformin and a Secretagogue - OPTIODiabetes mellitus tipo II controlada de forma subóptima con la combinación de metformina y un secretagogoType II diabetes Mellitus sub-optimally controlled on combination Metformin and a secretagogue.MedDRA version: 8.1Level: PTClassification code 10012601Term: Diabetes mellitusEUCTR2006-002245-36-ESMannKind Corporation525
进行中（未招募）
1 期
Ensayo fase III aleatorizado, multicéntrico, abierto, de grupos paralelos para comparar la eficacia y tolerabilidad de Fulvestrant (Faslodex®) durante tres años en combinación con Anastrozol (Arimidex®) durante 5 años versus Anastrozol durante 5 años como tratamiento hormonal adyuvante en mujeres posmenopáusicas con cáncer de mama temprano y receptores hormonales positivos.A randomized, multicentral, phase III study of parallel groups to compare the efficiency and tolerance of Fulvestrant (Faslodex) administered for three years in combination with Anastrozol (Arimidex) for 5 years versus Anastrozol for 5 years as adjuvant hormonotherapy in postmenopausal women with early breast cancer and positive hormonal receptors.Postmenopausal women with operable breast cancer and positive hormonal receptors who are eligible to be treated with adjuvant hormonotherapy.MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancerEUCTR2007-003417-14-ESGrupo Español de Investigación en Cáncer de Mama (GEICAM)3,180
进行中（未招募）
不适用
Ensayo de fase III, aleatorizado y multicéntrico, en sujetos mayores de 70 años con cáncer de pulmón de célula no pequeña en estadio IV, comparativo de una estrategia clásica de asignación al tratamiento (terapia de agente doble basada en carboplatino o monoterapia con docetaxel) según el performance status y la edad, con una estrategia optimizada de asignación a los mismos tratamientos según una escala de evaluación geriátrica simple, además de una evaluación geriátrica más minuciosa si fuera necesaria. - ESOGIAPacientes con cáncer de pulmón de célula no pequeña en estadío IVEUCTR2008-008372-13-ESHospital Universitario de Rennes490
进行中（未招募）
不适用
Ensayo de fase III, multicéntrico, aleatorizado, en doble ciego, controlado con placebo y de grupos paralelos, sobre la eficacia y la seguridad del bapineuzumab (AAB-001, ELN115727) en pacientes con enfermedad de Alzheimer de grado leve a moderado que no son portadores de la apolipoproteína E (ApoE) e4A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E e4 Non-carriersEnfermedad de AlzheimerAlzheimer DiseaseMedDRA version: 9.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeEUCTR2007-005994-79-ESWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development1,250
进行中（未招募）
不适用
Ensayo de fase III, multicéntrico, aleatorizado, en doble ciego, controlado con placebo y de grupos paralelos, sobre la eficacia y la seguridad del bapineuzumab (AAB-001, ELN115727) en pacientes con enfermedad de Alzheimer de grado leve a moderado que son portadores de la apolipoproteína E (ApoE) e4A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Mild to Moderate Alzheimer Disease Who Are Apolipoprotein E e4 CarriersEnfermedad de AlzheimerAlzheimer DiseaseMedDRA version: 9.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeEUCTR2007-005995-14-ESWyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development800