EUCTR2005-003216-30-ES进行中（未招募）1 期
Ensayo clínico de fase II prospectivo, multicéntrico, aleatorizado de grupos paralelos, abierto, para estudiar la eficacia, seguridad y tolerabilidad de 2 dosis de ZK 219477 (16 y 12 mg/m2 de área de superficie corporal) en pacientes con cáncer de mama metastásico
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Schering AG
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
入选标准
- •1. Females aged >/= 18 years
- •2. Histologically proven (at diagnosis), metastatic breast cancer
- •3. At least 1 unidimensionally measurable lesion (suitable for modRECIST evaluation)
- •4. Performance status: WHO 0-1
- •5. Progression of disease following a maximum of two previous steps of chemotherapy, including treatments in an adjuvant or neoadjuvant setting
- •6. No previous taxane or vinca alkaloid treatment
- •7. No more than 1 non cytotoxic therapy (biologic agents)
- •8. No radiotherapy, chemotherapy, or immune/biologic therapy within 3 weeks prior to first dose of ZK 219477
- •9. Adequate recovery from previous surgery, radiation, and chemotherapy
- •10. Adequate function of major organs and systems
- •Hematopoietic:
- •- Hemoglobin >/= 10 g/dL
- •- WBC >/= 3,000/mm3
- •- Absolute neutrophil count >/= 1,500/mm3
- •- Platelet count >/= 100,000/mm3
- •- Bilirubin within normal limits
- •- Creatinine
- •Cardiovascular:
- •- No New York Heart Association (NYHA) class III or IV
- •heart failure (see Attachment 4)
- •- No unstable angina pectoris
- •- No arrhythmia needing continuous treatment
- •No other uncontrolled concurrent illness
- •11. Negative pregnancy test at enrollment (females of childbearing potential only)
- •12. Agreement to use highly effective contraception methods (intra-uterine contraceptive device [IUCD], condoms, oral contraceptives, or other adequate barrier contraception) in females of child-bearing potential
- •13. In case the patients participate in the optional PET-Scan substudy: Able to tolerate PET imaging
- •14. Written informed consent
- •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. More than 2 previous chemotherapy regimens (including those given in an adjuvant or neo-adjuvant setting)
- •2. Peripheral neuropathy
- •3. Any prior treatment with epothilones
- •4. Use of any investigational drug within 4 weeks before start of study treatment or inadequate recovery from any toxic effects of such therapy
- •5. Candidacy for curative resection
- •6. Brain metastases requiring whole-brain irradiation
- •7. Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
- •8. Active infection
- •9. Breast-feeding
- •10. Any conditions that in the opinion of the investigator could hamper the compliance with the study protocol
- •11. In case the patients participate in the optional PET-Scan substudy: Poorly controlled diabetes defined as fasting glucose levels of >200 mg/dL.
研究者
相似试验
进行中（未招募）
1 期
Ensayo clínico multicéntrico, abierto, de Fase II con doxorubicina liposomal pegilada (Caelyx®) como tratamiento Primario en pacientes con cáncer de mama y antecedentes de Cardiopatía o con Edad superior a 65 años (CAPRICE). - CAPRICECáncer de mama primario invasivo histológicamente confirmado.MedDRA version: 9.1Level: LLTClassification code 10006190Term: Breast cancer invasive NOSEUCTR2007-001428-11-ESSOLTI66
进行中（未招募）
不适用
Etude prospective multicentrique de phase II évaluant la radioimmunothérapie fractionnée avec un anticorps humanisé anti-CD22 marqué à l'yttrium 90 (90Y-DOTA-hLL2) en consolidation après immuno-chimiothérapie R-CHOP dans les lymphomes B agressifs disséminés du sujet de plus de 60 ans - RIT 90Y-DOTA-hLL2EUCTR2007-002414-19-FRGOELAMS
进行中（未招募）
1 期
Etude prospective multicentrique de phase II évaluant l’adjonction du rituximab et du DepoCyte® en intrathécal au protocole de chimiothérapie C5R chez les patients âgés de 18 à 60 ans porteurs de lymphomes non hodgkiniens cérébraux primitifs et de lymphomes systémiques diffus à grandes cellules B avec envahissement neuro-méningé au diagnostic.EUCTR2006-000454-44-FRGroupe d’Etude des Lymphomes de l’Adulte (GELA)60
进行中（未招募）
1 期
Etude évaluant l'adjonction du rituximab et du DepoCyte au traitement de référence chez les patients de 18 à 60 ans porteurs de lymphomes non hodgkiniens cérébraux primitifs et de lymphomes systémiques diffus à grandes cellules B avec envahissement neuro-méningé au diagnosticPatiens with primary cerebral or oculocerebral NHL not previously treated with chemotherapy or radiotherapy and diffuse large B-cell lymphomas, with cerebral and / or neuromeningeal involvement at diagnosisMedDRA version: 14.1Level: LLTClassification code 10012820Term: Diffuse large B-cell lymphoma NOSSystem Organ Class: 100000004864EUCTR2006-000454-44-BEThe lymphoma Study Association (LYSA)106
进行中（未招募）
不适用
Ensayo clínico fase II no controlado, multicéntrico y prospectivo para determinar el beneficio clínico y toxicidad de Pazopanib, inhibidor multidiana de receptores con actividad tirosin-quinasa (VEGFR -1, -2 , -3, PDGFR-alfa; y beta; y C-Kit), en pacientes con cáncer de ovario avanzado platino resistentesEUCTR2010-020439-38-ESGrupo Español de Investigación en Cáncer de Ovario (GEICO)