EUCTR2010-024355-85-ES进行中（未招募）1 期
Ensayo de fase II aleatorizado, doble ciego, controlado con placebo para evaluar la seguridad y la eficacia de ASCI recMAGE-A3 + AS15 en pacientes con cáncer de vejiga músculo-invasivo positivo para MAGE-A3 tras cistectomía - MAGNOLIA
EAU Research Foundation0 个研究点目标入组 273 人开始时间: 2011年11月11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
- 273
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. Aged greater than or equal to 18 years at the time ICF is signed, either sex.
- •2. Histologically confirmed (after cystectomy) transitional cell carcinoma of bladder urothelium which is MAGE-A3 positive.
- •3. Written informed consent for tissue and (optional) urine sampling, MAGE-A3 expression analysis and gene profiling and optional translational research has been obtained from the patient prior to cystectomy, and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
- •4. TNM classification at pathological examination of surgically removed specimen: Stage T2,3 N0 or N1 or N2 and M0 disease or Stage T4 N0 M0 disease.
- •5. The patient is free of residual disease and free of metastasis, as confirmed by a negative baseline Computer Tomogram (CT scan) or Magnetic Resonance Imaging (MRI) of the pelvis, abdomen and chest no more than 9 weeks prior to randomization. Other examinations should be performed as clinically indicated.
- •6. Patient is fully recovered from surgery within 9 weeks following cystectomy.
- •7. The patient must have adequate bone-marrow reserve, defined as an absolute neutrophil count = 1.0 x 109/L, and a platelet count = 75 x 109/L, adequate renal function, defined as a serum creatinine = 1.5 times the Upper Limit of Normal (ULN), and adequate hepatic function, defined as a Total bilirubin = 1.5 times the ULN, and a Alanine transaminase (ALAT) and Aspartate Transaminase (ASAT) = 2.5 times the ULN as assessed by standard laboratory criteria.
- •8. World Health Organization (WHO) performance status 0 – 1 at the time of randomization.
- •9. If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
- •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 273
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The patient has previous or concomitant malignancies at other sites except effectively treated non-melanoma skin cancer, cervical carcinoma in situ, incidental localised prostatic carcinoma or effectively treated malignancy that has been in remission for over 5 years.
- •2. The patient has received any anti cancer systemic treatment, including immunotherapy(local intravesical BCG is allowed), chemotherapy, or neo-adjuvant chemotherapy, except:
- •* For the treatment of previous malignancies as allowed by the protocol (i.e., nonmelanoma skin cancer, cervical carcinoma in situ, incidental localised prostatic carcinoma or effectively treated malignancy that has been in remission for over 5 years).
- •3. The patient has received radiotherapy of the abdominal or pelvic region, within 6 months prior to randomization.
- •4. Women who are pregnant or breast feeding.
- •5. The patient has a known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C.
- •6. The patient has a history of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
- •7. The patient has any confirmed or suspected immunosuppressive or immunodeficient condition or potential immune-mediated diseases. Patients with vitiligo are not excluded to participate in the trial.
- •8. Patient has received a major organ allograft.
- •9. The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. Note: the use of prednisone, or equivalent, < 0,125 mg/kg/day (absolute maximum 10 mg/day), or inhaled corticosteroids or topical steroids is permitted.
- •10. The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study.
- •11. The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
- •12. The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. For example, but not limited to: uncontrolled congestive heart failure or uncontrolled hypertension, unstable heart disease (coronary heart disease or myocardial infarction) or uncontrolled arrhythmia.
- •13. The patient uses alternative treatments eg. plantextracts.
研究者
相似试验
进行中（未招募）
不适用
Ensayo de fase IIb, aleatorizado, doble ciego, controlado con placebo, para eltratamiento de la enfermedad celíaca activa con AT-1001Enfermedad celiaquia activaMedDRA version: 9.1Level: LLTClassification code 10007864Term: Celiac diseaseEUCTR2008-000415-14-ESAlba Therapeutics150
进行中（未招募）
1 期
Ensayo fase II, doble ciego, aleatorizado, controlado con placebo, para evaluar la eficacia de AZD6244 (hidrógeno-sulfato), en combinación con Docetaxel, comparado con Docetaxel en monoterapia, en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico (estadío IIIB - IV) con mutación KRAS positiva en 2ª línea de tratamientoA Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Docetaxel, Compared with Docetaxel Alone, in 2nd Line Patients with KRAS Mutation Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)2ª línea de tratamiento en pacientes con cáncer de pulmón no microcítico localmente avanzado o metastásico (estadío IIIB - IV) con mutación KRAS positiva 2nd Line Patients with KRAS Mutation Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV)MedDRA version: 9.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIBMedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IVMedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastaticEUCTR2008-006323-31-ESAstraZeneca AB87
进行中（未招募）
不适用
Ensayo en fase IIa, aleatorizado, doble ciego, controlado con placebo y de comparación intra-individual entre los miembros izquierdo-derecho en 25 pacientes con dermatitis atópica moderada, para investigar la eficacia, irritación local, seguridad, tolerabilidad y farmacocinética de la aplicación tópica dos veces al día con crema ImCOOH al 10% durante 14 días y una aplicación adicional en el día 15. (Phase IIa, randomized, double-blind, placebo-controlled, intra-individual left-right limb comparison trial in 25 patients with moderate atopic dermatitis to investigate the efficacy, local irritation, safety, tolerability and pharmacokinetics of twice daily topical applications with 10% ImCOOH cream for 14 days with an additional morning application on Day 15.)dermatitis atópica (atopic dermatitis)MedDRA version: 9.1Level: LLTClassification code 10012438Term: Dermatitis atopicEUCTR2007-004011-54-ESValletta Health BV
进行中（未招募）
1 期
Ensayo en fase II, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ZD6474 en combinación con Arimidexâ?frente a Arimidexâ?solo como tratamiento de segunda línea en pacientes con cáncer de mama avanzado (CMA) hormonosensible (receptores de estrógeno positivos y/o receptores de progesterona positivos).Cáncer de mama avanzado (CMA) hormono sensible (ER+ve y/o PR+ve)EUCTR2005-003591-38-ESAstraZeneca AB64
进行中（未招募）
不适用
Ensayo de fase 2, aleatorizado, en simple ciego y controlado con placebo, de la seguridad, la capacidad inmunógena y la tolerabilidad de la vacuna rLP2086 frente al meningococo de serogrupo B (MnB) a dosis de 60 microgramos, 120 microgramos y 200 microgramos en adolescentes sanos de 11 a 18 añosA Randomized, Single-Blind, Placebo-Controlled, Phase 2 Trial of the Safety, Immunogenicity, and Tolerability of Meningococcal Serogroup B (MnB) rLP2086 Vaccine at Doses of 60 micrograms, 120 micrograms, and 200 micrograms in Healthy Adolescents Aged 11 to 18 YearsVacuna rLP2086 frente al meningococo de serogrupo BThe test is a vaccine. The subjects are healthy adolescents.MedDRA version: 9.1Level: LLTClassification code 10027202Term: Meningitis bacterialEUCTR2008-007789-51-ESWyeth Research Division of Wyeth Pharmaceuticals Inc.715