European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
The first molecular profiling protocols have been launched in Europe (MOSCATO-01 (Geoerger
2014), MAPPYACTS, INFORM, iTHER, SM-PAEDS, etc.) determining multiple actionable alterations
in pediatric recurrent cancers. Increasingly, stratified approaches are being implemented to
enrich clinical trials of molecularly targeted agents and possibly improve outcomes in
specific populations i.e. a molecularly enriched/predictive biomarker-driven approach. The
diversity and heterogeneity of the detected molecular alterations and the low number of
pediatric patients mandate an adapted, innovative trial design for the attributed treatment
options in order to satisfy the current unmet medical need.
This basket trial is designed to cover the targeting of several survival pathways in
oncogenesis that are currently not adequately employed for pediatric patients in Europe.