Actively Recruiting
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2026-01-16
472
Participants Needed
21
Research Sites
756 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
N
National Cancer Institute, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with a blood or solid tumor cancer that has progressed despite standard therapy or has no effective standard therapy
- Younger than 18 years at inclusion; patients 18 years or older may be included after sponsor discussion if they have pediatric recurrent/refractory cancer
- Must have advanced molecular profiling of recurrent or refractory tumor, usually at disease progression or relapse
- Have measurable or evaluable disease by standard imaging criteria for their tumor
- Eligible if they have relapsed or refractory leukemia
- Performance status score of 70% or higher (Karnofsky for >12 years or Lansky Play score for 3 years)
- Life expectancy of at least 3 months
- Adequate organ function including blood counts, heart function, kidney and liver tests as specified
- Able to comply with follow-up and manage treatment toxicity
- Females of childbearing potential must have negative pregnancy test within 72 hours before treatment and agree to contraception during and 6 months after study
- Sexually active males must agree to use condoms during and for 6 months (7 months for arm J) after treatment
- Able to swallow capsules or use nasogastric/gastrostomy feeding tubes if necessary
- Written informed consent and age-appropriate assent obtained
- Affiliated with social security according to local rules
You will not qualify if you...
- Symptomatic unstable central nervous system metastases needing increased corticosteroids or CNS therapy; stable doses for 7 days allowed
- Gastrointestinal issues that affect oral drug absorption like ulcers, severe nausea, vomiting, diarrhea, or malabsorption
- Uncontrolled significant heart disease or arrhythmias, unstable ischemia, or heart failure within 12 months
- Active viral hepatitis, HIV infection, or uncontrolled infections
- Presence of treatment-related toxicity grade 2 or higher except hair loss, ear toxicity, or peripheral neuropathy
- Recent systemic anticancer therapy within 21 days or 5 times half-life before study
- Recent myeloablative therapy with stem cell rescue within 8 weeks
- Allogeneic stem cell transplant within 3 months; patients on treatment for graft-versus-host disease excluded
- Recent non-palliative radiotherapy within 21 days (or 6 weeks for some therapies)
- Major surgery within 21 days except minor procedures with 48-hour gap before treatment
- Taking medications that prolong QT interval or cause serious heart rhythm effects
- Taking drugs mainly metabolized by certain enzymes or transporters with low therapeutic index that cannot be stopped before and during study
- Known allergy to study drugs or their ingredients
- Pregnant or breastfeeding females
- Received live vaccines within 4 weeks before starting study drug
AI-Screening
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Trial Site Locations
Total: 21 locations
1
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
2
Gustave Roussy
Villejuif, Val De Marne, France, 94805
Actively Recruiting
3
CHU Angers
Angers, France, 49933
Actively Recruiting
4
CHU Pellegrin
Bordeaux, France, 33076
Actively Recruiting
5
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
6
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
7
Hôpital de La Timone
Marseille, France, 13385
Actively Recruiting
8
CHU Nantes
Nantes, France, 44093
Actively Recruiting
9
Institut Curie
Paris, France, 75005
Actively Recruiting
10
Hôpital Armand Trousseau
Paris, France, 75012
Actively Recruiting
11
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Actively Recruiting
12
Ospedale Infantile Regina Margherita
Torino, Italy, 10126
Not Yet Recruiting
13
Prinses Maxima Centrum
Utrecht, Netherlands, 3584 EA
Active, Not Recruiting
14
Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
15
Hospital del Nino Jesus
Madrid, Spain, 28009
Actively Recruiting
16
Hospital Universitario La Fe
Valencia, Spain, 46026
Actively Recruiting
17
Birmingham Children's Hospital
Birmingham, United Kingdom, B4 6NH
Actively Recruiting
18
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH
Actively Recruiting
19
Royal Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Actively Recruiting
20
Royal Victoria Infirmary
Newcastle, United Kingdom, NE1 4LP
Actively Recruiting
21
Pediatric and Adolescent Oncology The Royal Marsden Hospital
Sutton, United Kingdom
Actively Recruiting
Research Team
B
Birgit Geoerger, MD
CONTACT
E
Estelle Jullemier, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
18
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