03 febrero 2009

J & J Va terminando la Fase II del Yondelis en Treatment of Localized Myxoid / Round Liposarcoma . not recruiting participants .

The purpose of this study is to determine the effects that trabectedin has on Myxoid / round cell liposarcoma (MRCL) when it is given before the tumor is removed by surgery.

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Primary Outcome Measures:
To determine the pathological complete response (pCR) rate with trabectedin in patients with localized myxoid / round cell liposarcoma (MRCL)
Secondary Outcome Measures:
Evaluate objective response rate by RECIST & contrast such responses with changes in radiological density & tumor pathology. Describe the incidence & severity of adverse events in this patient population; hypothesis-generating pharmacogenomic analyses

Estimated Enrollment: 22
Study Start Date: May 2007
Last Updated: January 29, 2009