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11054 : BERNIE: Open-label, randomized, phase II study of bevacizumab plus chemotherapy in pediatric metastatic rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).

Researchers

Presenter

  • Julia C. Chisholm

Principal Investigators

  • Johannes H. Merks

  • Michela Casanova

  • Gianni Bisogno

  • Daniel Orbach

  • Jean-Claude Gentet

  • Anne-Sophie Thomassin Defachelles

  • Pascal B. Chastagner

  • Steve Lowis

  • Milind Ronghe

  • Kieran McHugh

  • Rick R. van Rijn

  • Magalie Hilton

  • Jeanette Bachir

  • Sabine Furst-Recktenwald

  • Birgit Geoerger

  • Odile Oberlin

Medical Centers

  • The Royal Marsden Hospital NHS Foundation Trust, London & Surrey, United Kingdom

  • Academic Medical Center, Amsterdam, Netherlands

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

  • Clinica di Oncoematologia Pediatrica, Universita degli Studi di Padova, Padova, Italy

  • Institut Curie, Paris Cedex, France

  • Hopital pour Enfants de La Timone, Marseille, France

  • Centre Oscar Lambret, Lille, France

  • Hopital de Brabois Adultes, Vandoeuvre-Les-Nancy, France

  • Bristol Royal Hospital for Children, Bristol, United Kingdom

  • Royal Hospital for Sick Children, Glasgow, United Kingdom

  • Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom

  • F. Hoffmann-La Roche Ltd., Basel, Switzerland

  • Gustave Roussy, Villejuif, France

  • Institut Gustave-Roussy, Villejuif, France

Locations

  • Italy

  • Netherlands

  • United Kingdom

  • Switzerland

  • France

Companies

  • F. Hoffmann-La Roche

Study Components

Therapeutic Area

  • Genetic Disorder

  • Musculoskeletal

Disease

  • Non-rhabdomyosarcoma soft tissue sarcoma

  • Short stature, onychodysplasia, facial dysmorphism, and hypotrichosis

Biomarkers

  • N/A

Drug/Treatment

  • Cyclophosphamide

  • Cyclophosphamide Injection

  • Bevacizumab

  • Vinorelbine

  • Vincristine

  • Doxorubicin

  • Ifosfamide

Outcome

  • Indeterminate


Study Design

  • Randomized

  • Pharmacokinetics

  • Open Label

Phase

  • II

Study Id's

  • NCT00643565

Sponsors

  • N/A

Result

  • Final