Trial of Afatinib in Pediatric Tumours

Study Purpose

Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

- Paediatric patients aged 1 year to <18 years at the time of informed consent - diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation - recurrent/refractory disease after they received at least one prior standard treatment regimen - no effective conventional therapy exists - Performance status >= 50% (Lansky for =<12ys; Karnofsky for >12ys) - Further inclusion criteria apply

Exclusion criteria:

- relevant toxicity from previous treatment - known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis - Further exclusion criteria apply

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02372006
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Boehringer Ingelheim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Boehringer Ingelheim
Principal Investigator Affiliation Boehringer Ingelheim
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Austria, Canada, Denmark, Faroe Islands, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neuroectodermal Tumors, Rhabdomyosarcoma
Arms & Interventions

Arms

Experimental: afatinib

dose escalation

Interventions

Drug: - afatinib

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Suspended

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

The University Of Texas at Houston, Houston, Texas

Status

Suspended

Address

The University Of Texas at Houston

Houston, Texas, 77030

University of Wisconsin, Madison, Wisconsin

Status

Suspended

Address

University of Wisconsin

Madison, Wisconsin, 53792

International Sites

Sydney Children's Hospital, Randwick, New South Wales, Australia

Status

Suspended

Address

Sydney Children's Hospital

Randwick, New South Wales, 2031

AKH - Medical University of Vienna, Vienna, Austria

Status

Completed

Address

AKH - Medical University of Vienna

Vienna, , 1090

Wien, Austria

Status

Recruiting

Address

St. Anna Children-Hospital, Children's Cancer Research, Wien

Wien, , 1090

The Hospital for Sick Children, Toronto, Ontario, Canada

Status

Completed

Address

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8

København Ø, Denmark

Status

Completed

Address

Rigshospitalet, København, Børneonkologisk Afsnit 5002

København Ø, , 2100

HOP Toulouse, Pédiat, Toulouse, Toulouse, Faroe Islands

Status

Recruiting

Address

HOP Toulouse, Pédiat, Toulouse

Toulouse, , 31059

HOP Pellegrin, Bordeaux, France

Status

Completed

Address

HOP Pellegrin

Bordeaux, , 33076

CTR Oscar Lambret, Lille, France

Status

Completed

Address

CTR Oscar Lambret

Lille, , 59020

CTR Leon Berard, Lyon, France

Status

Completed

Address

CTR Leon Berard

Lyon, , 69008

INS Curie, Paris, France

Status

Completed

Address

INS Curie

Paris, , 75248

INS Gustave Roussy, Villejuif, France

Status

Completed

Address

INS Gustave Roussy

Villejuif, , 94805

Charité - Universitätsmedizin Berlin, Berlin, Germany

Status

Suspended

Address

Charité - Universitätsmedizin Berlin

Berlin, , 13353

Universitätsklinikum Essen AöR, Essen, Germany

Status

Suspended

Address

Universitätsklinikum Essen AöR

Essen, , 45147

Universitätsklinikum Tübingen, Tübingen, Germany

Status

Suspended

Address

Universitätsklinikum Tübingen

Tübingen, , 72076

Children's Health Ireland at Crumlin, Dublin, Ireland

Status

Suspended

Address

Children's Health Ireland at Crumlin

Dublin, , D12 N512

Istituto G. Gaslini, Genova, Italy

Status

Suspended

Address

Istituto G. Gaslini

Genova, , 16147

Milano, Italy

Status

Suspended

Address

Fondazione IRCCS Istituto Nazionale dei Tumori

Milano, , 20133

Padova, Italy

Status

Suspended

Address

Azienda Ospedaliera Universitaria di Padova

Padova, , 35128

Osp. Pediatrico Bambin Gesù, Roma, Italy

Status

Suspended

Address

Osp. Pediatrico Bambin Gesù

Roma, , 00165

Erasmus MC - Sophia Kinderziekenhuis, Rotterdam, Netherlands

Status

Terminated

Address

Erasmus MC - Sophia Kinderziekenhuis

Rotterdam, , 3015 CN

Utrecht, Netherlands

Status

Recruiting

Address

Prinses Maxima centrum voor kinderoncologie

Utrecht, , 3584 CS

Hospital Vall d'Hebron, Barcelona, Spain

Status

Suspended

Address

Hospital Vall d'Hebron

Barcelona, , 08035

Madrid, Spain

Status

Suspended

Address

Hospital Infantil Universitario Niño Jesus

Madrid, , 28009

Hospital Politècnic La Fe, Valencia, Spain

Status

Suspended

Address

Hospital Politècnic La Fe

Valencia, , 46026

Birmingham Children's Hospital, Birmingham, United Kingdom

Status

Suspended

Address

Birmingham Children's Hospital

Birmingham, , B4 6NH

Great Ormond Street Hospital, London, United Kingdom

Status

Suspended

Address

Great Ormond Street Hospital

London, , WC1N 3BN

Royal Manchester Children's Hospital, Manchester, United Kingdom

Status

Suspended

Address

Royal Manchester Children's Hospital

Manchester, , M13 9WL

The Royal Marsden Hospital, Sutton, United Kingdom

Status

Suspended

Address

The Royal Marsden Hospital

Sutton, , SM2 5PT

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