A Phase I/II Safety and Exploratory Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects with Relapsed/Refractory Solid Tumors

Mise à jour : Il y a 4 ans
Référence : EUCTR2007-000371-42

Femme et Homme

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Extrait

Part 1 (Part 1 is now closed): Primary Objective - To evaluate the safety of IV temsirolimus given once weekly to children with solid tumors with disease that is recurrent or refractory to standard therapy or for whom standard therapy is not available. Part 2: Primary objective - To obtain preliminary information on the anti-tumor activity of IV temsirolimus in children with relapsed/refractory neuroblastoma, high-grade glioma, and rhabdomyosarcoma. Anti-tumor activity will be assessed by determining the percentage of subjects exhibiting objective response (CR + PR) within 12 weeks.


Critère d'inclusion

  • Relapsed/refractory neuroblastoma,high-grade glioma, and rhabdomyosarcoma