View of NCT01692678 on 2013-10-23 .
Ensayo de Fase III que se inició en China de la mano de Xian - Janssen hace poco más de un año .
Descriptive Information :
Brief title : A Study of Trabectedin (YONDELIS) in Patients With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma .
Brief summary :
The purpose of this study is to find the optimal dose of trabectedin for Chinese patients with locally advanced or metastatic L-sarcoma (liposarcoma or leiomyosarcoma) who were previously treated (in any order) with at least an anthracycline and ifosfamide containing regimen, or an anthracycline containing regimen and 1 additional cytotoxic chemotherapy regimen (Part 1) and to evaluate whether the overall survival (OS) of the trabectedin group is superior to dacarbazine group (Part 2).
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Recruitment Information :
Status : Recruiting
Start date : 2012-08
Last follow-up date : 2018-03 (Anticipated)
Primary completion date : 2014-10 (Anticipated)
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Administrative Data :
Organization name : Xian-Janssen Pharmaceutical Ltd.
Organization study ID : CR017269
Secondary ID : ET743SAR3006 (Xian-Janssen Pharmaceutical Ltd., China)
Sponsor : Xian-Janssen Pharmaceutical Ltd.
Health Authority China : Food and Drug Administration
Health Authority China : Ethics Committee
Ovarian cancer : Some women with high-risk disease may benefit from bevacizumab
Bevacizumab, a recombinant humanised monoclonal antibody against vascular endothelial growth factor (VEGF), does not improve survival in women with newly diagnosed ovarian cancer. However, there may be a clinically meaningful survival gain in high-risk subgroups and in patients with platinum-resistant ovarian cancer.
Bevacizumab is an effective inhibitor of angiogenesis that has shown to extend progression-free survival (PFS) of women with advanced ovarian cancer, according to findings from phase III clinical trials. Therefore, the final analyses of overall survival have been eagerly anticipated.
The phase III trial ICON7 examined the effect of bevacizumab on survival in women with newly diagnosed ovarian cancer. Primary analysis of progression-free survival demonstrated benefit from addition of bevacizumab to standard chemotherapy.
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The authors concluded that in women with newly diagnosed ovarian cancer, bevacizumab in addition to carboplatin and paclitaxel, did not improve survival by a clinically important magnitude. However, in a prespecified subgroup at high risk of progression, a benefit of 4.8 months in the restricted mean survival time is observed.
Three-month benefit in platinum-resistant patients
The phase III trial AURELIA investigated the efficacy and safety of bevacizumab in combination with a range of chemotherapies (including paclitaxel, topotecan and liposomal doxorubicin) in patients with
platinum-resistant ovarian cancer. Eligible patients had measurable/assessable ovarian cancer that had progressed less than six months after platinum therapy. The AURELIA trial met its primary endpoint, significantly improving PFS from 3.4 to 6.7 months. With median follow-up time of 27.4 months, 264 of 361 patients have died. Bevacizumab improved median overall survival 13.3 to 16.6 months compared with chemotherapy alone. However, this survival benefit did not reach statistical significance.
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El esteroide dexametasona podría bloquear la formación de células de cáncer hepático en modelo animal.
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La Asociación Española de Bioempresas (ASEBIO) y la Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS) organizan hoy en Málaga un encuentro de partnering para poner en contacto y fomentar la transferencia de la investigación sanitaria que se desarrolla en el Sistema Nacional de Salud hacia el sector biotecnológico.
El objetivo del partnering es el de facilitar contactos entre departamentos de innovación y transferencia de tecnología de hospitales españoles y las diferentes industrias interesadas en sus desarrollos (biotecnológica, farmacéutica, medical devices, TIC, etc.). Se han inscrito 90 entidades, entre las que se incluyen empresas, universidades, centros de investigación públicos y privados y hospitales, que han organizado 150 reuniones de desarrollo de negocio.
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• Gross sales of Yondelis® up to 30 September 2013 rose by
17.5% with respect to the same period in 2012.
• EBITDA for the oncology business grew 12% during the first nine months of the year compared to the same period last year, contributing 25.9 million Euros to the total Group EBITDA.
• Up to 30 September, the Zeltia Group registered an attributable net profit of 14 million Euros (+64.9% vs the same period last year) as a result of the concentration in the oncology business.
• The Group reduced its total debt by 13% with respect to the beginning of the year.
Madrid, 24 October 2013: During the first nine months of the year, gross sales of Yondelis® increased by 17.5% with respect to the same period last year. This increase is due, to a large extent, to the restoration of the supply of Caelyx® in May. Caelyx® is the drug administered in combination with Yondelis® for the treatment of relapsed ovarian cancer. Net sales of Yondelis® up to September 2013 were 53.2 million Euros which is a 7.2% increase year-on-year even after factoring in the price discounts applied by various European countries. Nevertheless, this increase represents 12% if we consider commercial sales only. That is, sales without taking into account the effect of the sale of raw material to our partners which took place in 2012.
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WASHINGTON, ESTADOS UNIDOS (24/OCT/2013).-
Eso es debido a que, por la noche, la parte de la residencia presidencial que hace frente con la Avenida Pensilvania ha sido bañada con luz rosa por el mes de concientización sobre el cáncer de mama.
El ancla del Observatorio Naval, donde está ubicada la residencia del vicepresidente, también iba a ser iluminada de rosa.
Jay Carney, vocero de la Casa Blanca, dijo que más de 230 mil mujeres serán diagnosticadas con cáncer de pecho este año en el país, y que miles fallecerán por esa enfermedad.
Carney hizo propaganda el jueves a favor de las pruebas de detección de cáncer de mama y otros servicios preventivos gratuitos disponibles en la nueva ley de salud; y señaló que a partir del próximo año, las compañías de seguros tendrán prohibido negar cobertura debido a condiciones de preexistencia, incluido el cáncer de pecho.
View of NCT01692678 on 2013-10-23 .