View of NCT00070109 on 2009_09_28
ClinicalTrials Identifier: NCT00070109
Updated: 2009_09_28
Descriptive Information
Brief title Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
Official title A Phase II Study Of Trabectedin (ET-743, Yondelis®) in Children With Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcomatous Soft Tissue Sarcoma
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Un ensayo que empezo en 2005 :
View of NCT00070109 on 2005_06_23
ClinicalTrials Identifier: NCT00070109
Updated: 2005_06_23
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30 septiembre 2009
J&J actualiza el ensayo del Yondelis en Cancer de Mama en Fase II - III .
Ensayo Clinico que J&J inicio en Enero del 2007 .
View of NCT00580112 on 2009_09_28
ClinicalTrials Identifier: NCT00580112
Updated: 2009_09_28
*.- Official title Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis�) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers
*.- Brief summary
The purpose of this study is to evaluate the effectiveness and safety of Trabectedin in three subpopulations of breast cancer patients.
*.- Detailed description
This is an open-label, clinical trial evaluating the effectiveness and safety of trabectedin in three subpopulations of breast cancer patients: Group A: triple negative profile (ER-, PR-, HER-2-), Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) and Group C: familial BRCA1 or BRCA2 mutation carrier. Each subtype is defined according to the estrogen, progesterone, and the Human Epidermal Growth Factor Receptor- 2 (HER-2) status in the primary tumor (present or overexpressing = positive or absent or do not overexpressing = negative) or the history of having BRCA1 or BRCA2 mutation genes. Trabectedin will be administered intravenously every three weeks. Patients will be assessed weekly physical exam and / or laboratory testing. Radiological examination will occur every 6 weeks to evaluate the patient's disease. Treatment will continue as long as the patient tolerating trabectedin and their disease is stable or improving. Duration of response, progression free-survival, exploratory evaluation of changes in tumor volume and changes in tumoral radiological density, safety profile and exploratory, hypothesis-generating pharmacoecogenomic analyses will be assessed.Patients are evaluable for safety if they received at least part of one infusion of trabectedin. Safety will be assessed by adverse events, laboratory measurements, and clinical examinations Trabectedin will be administered intravenously at a dose of 1.3 mg/m2 over 3-hours on Day 1 of every 21-day treatment cycle
Phase Phase 3
Study type Interventional
Study design Treatment
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View of NCT00580112 on 2009_09_28
ClinicalTrials Identifier: NCT00580112
Updated: 2009_09_28
*.- Official title Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis�) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers
*.- Brief summary
The purpose of this study is to evaluate the effectiveness and safety of Trabectedin in three subpopulations of breast cancer patients.
*.- Detailed description
This is an open-label, clinical trial evaluating the effectiveness and safety of trabectedin in three subpopulations of breast cancer patients: Group A: triple negative profile (ER-, PR-, HER-2-), Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) and Group C: familial BRCA1 or BRCA2 mutation carrier. Each subtype is defined according to the estrogen, progesterone, and the Human Epidermal Growth Factor Receptor- 2 (HER-2) status in the primary tumor (present or overexpressing = positive or absent or do not overexpressing = negative) or the history of having BRCA1 or BRCA2 mutation genes. Trabectedin will be administered intravenously every three weeks. Patients will be assessed weekly physical exam and / or laboratory testing. Radiological examination will occur every 6 weeks to evaluate the patient's disease. Treatment will continue as long as the patient tolerating trabectedin and their disease is stable or improving. Duration of response, progression free-survival, exploratory evaluation of changes in tumor volume and changes in tumoral radiological density, safety profile and exploratory, hypothesis-generating pharmacoecogenomic analyses will be assessed.Patients are evaluable for safety if they received at least part of one infusion of trabectedin. Safety will be assessed by adverse events, laboratory measurements, and clinical examinations Trabectedin will be administered intravenously at a dose of 1.3 mg/m2 over 3-hours on Day 1 of every 21-day treatment cycle
Phase Phase 3
Study type Interventional
Study design Treatment
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J&J actualiza la Fase III que Evalua la Efectividad del Yondelis frente a la terapia Standar para 1ª Linea en Pacientes con Avanzado TRS .
Ensayo Clinico que J&J inicio en Noviembre del 2008 .
View of NCT00796120 on 2009_09_28
ClinicalTrials Identifier: NCT00796120
Updated: 2009_09_28
*.- A randomized, multicenter, Phase III trial to evaluate the effectiveness of trabectedin versus standard doxorubicin-based chemotherapy (DXCT) as first-line treatment of patients with advanced TRS, by comparing progression-free survival (PFS) in the two treatment arms.
*.- Detailed description
Treatment Arm A: Trabectedin. Treatment Arm B: Doxorubicin as a single agent or in combination with ifosfamide Trabectedin 1.5 mg/m2 given intravenously over 24-hours; or doxorubicin 75 mg/m2 intravenously every 3 weeks, or doxorubicin 60 mg/m2 intravenously followed by ifosfamide in the range of 6 to 9 g/m2 every 3 weeks with proper hydration and ifosfamide chemoprotectant drugs.
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View of NCT00796120 on 2009_09_28
ClinicalTrials Identifier: NCT00796120
Updated: 2009_09_28
*.- A randomized, multicenter, Phase III trial to evaluate the effectiveness of trabectedin versus standard doxorubicin-based chemotherapy (DXCT) as first-line treatment of patients with advanced TRS, by comparing progression-free survival (PFS) in the two treatment arms.
*.- Detailed description
Treatment Arm A: Trabectedin. Treatment Arm B: Doxorubicin as a single agent or in combination with ifosfamide Trabectedin 1.5 mg/m2 given intravenously over 24-hours; or doxorubicin 75 mg/m2 intravenously every 3 weeks, or doxorubicin 60 mg/m2 intravenously followed by ifosfamide in the range of 6 to 9 g/m2 every 3 weeks with proper hydration and ifosfamide chemoprotectant drugs.
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ActivoBank ( Banco Sabadell ) da un Precio Objetivo para Zeltia de 10,40 euros , le ve una revalorización de un 115,32 % .
Post by Pablont ...
4,83 x 115,32 % = 10,39 .
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FDA ha clasificado las instalaciones de Pharmamar como aptas para fabricar activos . Una Puerta que se abre .
PD :*.-LA FDA ACEPTA A PHARMAMAR COMO FABRICANTE DEL PRINCIPIO ACTIVO DE YONDELIS .
*.- Otro punto poco conocido ... el Yondelis que se Vende-utiliza en varios Paises de la Mano de Janssen Cylag ( J&J ) esta Elaborado por Baxter Oncology GMBH Kantstrasse 2 33790 Halle/Westfalen ALEMANIA.
Importado por JANSSEN CILAG Farmacéutica S.A.,
Lo Comunicado hoy :
Zeltia ha puesto una pica...en Nueva York. Y es que la Food and Drug Administration (FDA), el organismo equivalente a la Agencia Europea del Medicamento, ha clasificado las instalaciones de su filial Pharmamar -fabricante del medicamento estrella 'Yondelis' para el cáncer de ovario- como aptas para fabricar principios activos.
Con este resultado de la inspección, PharmaMar cumple con los requisitos y exigencias de las autoridades americanas para suministrar trabectedina para la fabricación de Yondelis para el mercado estadounidense.
Esta aceptación de PharmaMar como fabricante es una condición necesaria para el posterior suministro en el mercado americano en caso de que Centocor Ortho Biotech Inc. consiga la autorización de comercialización por parte de la FDA y, por tanto, no afecta a la decisión de la FDA comunicada el pasado 10 de septiembre que consideró que la combinación de Yondelis y Doxil no es aprobable por el momento, recomendando esperar a que se completen los datos finales de surpervivencia y se aporte información adicional para su evaluación, en un periodo comprandido entre los próximos 12 a 18 meses.
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