drugset
drugset / Trial / NCT02813135

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

NCT02813135 ↗

Phase 1/2 Recruiting 472 enrolled Gustave Roussy, Cancer Campus, Grand Paris Fight Kids Cancer · collabFondation ARC · collabNational Cancer Institute, France · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This proof-of-concept platform trial is designed to cover the targeting of several survival pathways in oncogenesis that are currently not adequately employed for pediatric patients in Europe (Geoerger 2017; Geoerger 2019). The aims of the trial are: 1. To determine the recommended phase II dose (RP2D) of a specific anticancer agent and/or a relevant combination in a pediatric population, to document its tolerability and 2. To explore first signals of activity in a molecularly enriched study population.

Timeline

Start
2016-08-03
Primary completion
2031-02
Completion
2031-02

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Adavosertib Small molecule — Oral
Subject Avelumab Monoclonal antibody — Intravenous
Subject CYC065 Small molecule 135 mg/m2 Intravenous
Subject Capivasertib Small molecule — Oral
Subject Capmatinib Small molecule — Oral
Subject Carboplatin Small molecule — Intravenous
Subject Ceralasertib Small molecule — Oral
Subject Cyclophosphamide Other / unclassified 25 mg/m2 Oral
Subject Cytarabine Small molecule — Intravenous
Subject Enasidenib Small molecule — Oral
Subject Everolimus Small molecule 2.5 mg/m2 Oral
Subject Futibatinib Small molecule — Oral
Subject Irinotecan Small molecule — Intravenous
Subject Lirilumab Monoclonal antibody — Intravenous
Subject NEDISERTIB Small molecule — Oral
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous
Subject Olaparib Small molecule — Oral
Subject Ribociclib Small molecule 175 mg/m2 Oral
Subject Ribociclib Small molecule 260 mg/m2 Oral
Subject Selumetinib Small molecule — Oral
Subject Temozolomide Small molecule 100 mg/m2 Oral
Subject Topotecan Small molecule 0.5 mg/m2 Intravenous
Subject Vinorelbine Small molecule — Oral
Subject Vistusertib Small molecule 30 mg/m2 Oral
Subject Vistusertib Small molecule 75 mg/m2 Oral
Background Dexamethasone Small molecule — Oral

Indications

childhood malignant neoplasm