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

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.

Conditions

• Pediatric Cancer

Interventions

DRUG

Ribociclib

DRUG

Topotecan

DRUG

Temozolomide

DRUG

Everolimus

DRUG

Adavosertib

DRUG

Carboplatin

DRUG

Olaparib

DRUG

Irinotecan

DRUG

Vistusertib

DRUG

Nivolumab

DRUG

Cyclophosphamide

DRUG

Selumetinib

DRUG

Enasidenib

DRUG

Lirilumab

DRUG

Fadraciclib

DRUG

Cytarabine

DRUG

Dexamethasone

DRUG

Ceralasertib

DRUG

Futibatinib

DRUG

Capmatinib

DRUG

Avelumab

DRUG

Peposertib

DRUG

Capivasertib

DRUG

Vinorelbine

Sponsors & Collaborators

• National Cancer Institute, France

  collaborator OTHER_GOV

• Fight Kids Cancer

  collaborator OTHER

• Fondation ARC

  collaborator OTHER

• Gustave Roussy, Cancer Campus, Grand Paris

  lead OTHER

Principal Investigators

• Birgit Geoerger, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-03

Primary Completion

2031-02-28

Completion

2031-02-28

Countries

• Denmark
• France
• Italy
• Netherlands
• Spain
• United Kingdom

Study Locations