EUCTR2006-000685-36-IT进行中（未招募）不适用
Studio randomizzato, in aperto di fase II per valutare efficacia e sicurezza di FOLFOX-4 piu' cetuximab rispetto a UFOX piu' cetuximab come terapia di prima linea in soggetti affetti da carcinoma del colon retto metastatico - Future
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 400
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
- •Signed written informed consent
- •Inpatient or outpatient >=18 years of age
- •Diagnosis of histologically confirmed
- •adenocarcinoma of the colon or rectum
- •First occurrence of metastatic disease (not curatively
- •resectable)
- •Presence of at least one lesion measurable uni
- •dimensionally by CT scan or MRI. (Target lesion(s)
- •must not lie within an irradiated area)
- •Life expectancy of >=3 months
- •Karnofsky performance status of >=60, at study entry
- •White blood cell count (WBC) >=3 x 109/L, with
- •neutrophils >=1.5 x 109/L, platelets >=100 x 109/L, and
- •hemoglobin >=9 g/dL
- •AST and ALT <=2.5 x ULN (<=5 x ULN if liver
- •metastasis are present)
- •Normal serum creatinine (in case of elevated
- •creatinine, labelled EDTA clearance >65 mL/min is
- •acceptable)
- •Effective contraception for both male and female
- •subjects if the risk of conception exists
- •Tumor biopsy or archived sample available
- •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
- •Brain metastasis and/or leptomeningeal disease
- •(known or suspected)
- •Previous chemotherapy for colorectal cancer except
- •adjuvant treatment with progression of disease
- •documented >6 months after end of adjuvant
- •Previous oxaliplatin-based chemotherapy
- •Surgery (excluding diagnostic biopsy) or irradiation
- •within 4 weeks prior to randomization
- •Concurrent or previous chronic systemic immune
- •therapy, targeted therapy, anti-VEGF therapy,
- •EGFR-pathway targeting therapy not indicated in the
- •study protocol
- •Concurrent hormonal therapy not indicated in the
- •study protocol except for physiologic replacement or
- •contraception
- •Clinically relevant coronary artery disease, history of
- •myocardial infarction in the last 12 months, or high
- •risk of uncontrolled arrhythmia
- •Peripheral neuropathy >grade 1
- •Known hypersensitivity reaction to any of the
- •components of the treatment.
- •Any concurrent malignancy other than basal cell
- •cancer of the skin, or pre-invasive cancer of the
- •cervix. (Subjects with a previous malignancy but
- •without evidence of disease for >=5 years will be
- •allowed to enter the study)
- •Pregnancy (absence to be confirmed by ß-hCG test)
- •or lactation period
- •Known drug abuse/alcohol abuse
- •Legal incapacity or limited legal capacity
- •Medical or psychological condition which in the
- •opinion of the investigator would not permit the
- •subject to complete the study or sign meaningful
- •informed consent
- •Participation in another clinical study within the
- •30 days before randomization
- •Significant disease which, in the investigator's
- •opinion, would exclude the subject from the study
研究者
相似试验
进行中（未招募）
1 期
Estudio de fase II, abierto, aleatorizado para evaluar la eficacia y seguridad de paclitaxel administrado semanalmente como agente único y dos regímenes diferentes de SAR240550 (BSI-201), un inhibidor de PARP-1, en combinación con paclitaxel semanal, como terapia neoadyuvante en pacientes con cáncer de mama triple negativo en estadio II-IIIA (TNBC)__________________________________________________Randomized, open-label, phase 2 study of the efficacy and safety of weekly paclitaxel single-agent and two different regimens of the PARP-1 inhibitor SAR240550 (BSI-201) in combination with weekly paclitaxel, as neoadjuvant therapy in patients with Stage II-IIIA triple negative breast cancer (TNBC) - SOLTI NEOPARPeoadyuvante en pacientes con cáncer de mama triple negativo en estadio II-IIIA (TNBC)_______________________________________________ Neoadjuvant TNBCMedDRA version: 12.1Level: LLTClassification code 10057654Term: Breast cancer femaleEUCTR2010-018960-17-ESsanofi-aventis recherche & développement
进行中（未招募）
1 期
Estudio en fase 1/2, abierto y aleatorizado de la seguridad, eficacia y farmacocinética de letrozol más PD 0332991 (inhibidor oral de CDK 4/6) y letrozol en monoterapia, para el tratamiento en primera línea del cáncer de mama avanzado RE-positivo y Her2-negativo en mujeres posmenopáusicasPHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMENT OF ER POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN - n/aCancer de Mama avanzado Advanced Breast CancerMedDRA version: 9.1Level: LLTClassification code 10027475Term: Metastatic breast cancerEUCTR2008-002392-27-ESPFIZER150
进行中（未招募）
不适用
Estudio de fase II, aleatorizado, abierto (con grupos de control enmascarados de activador del plasminógeno y placebo) para evaluar los efectos de distintos regímenes de infusión intratrombo de plasmina (humana) en comparación con activador del plasminógeno y placebo en pacientes con oclusión aguda de una arteria nativa de las extremidades inferiores o de un injerto de derivacióEUCTR2010-019760-36-ESTalecris Biotherapeutics, Incorporated100
进行中（未招募）
不适用
Estudio fase II abierto, no aleatorizado, para evaluar la eficacia y seguridad del tratamiento neoadyuvante concomitante de Gemcitabina y Erlotinib seguido de Gemcitabina, Erlotinib y radioterapia en pacientes con adenocarcinoma resecable de páncreas.Adenocarcinoma de páncreas resecableEUCTR2010-021738-72-ESGEMCAD
进行中（未招募）
1 期
Etude de phase II ouverte évaluant en fonction du polymorphisme du CYP2D6, le taux de réponse biologique au traitement par tamoxifène (TAM) administré en situation pré-opératoire chez des patientes présentant un cancer du sein non métastatique RH+ - TAMEUCTR2008-007652-10-FRCentre René Gauducheau