Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2015-04-29
2020-08-05
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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afatinib
dose escalation
afatinib
Interventions
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afatinib
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* known pre-existing relevant cardiac , hepatic, renal, bone marrow dysfunction, ILD, keratitis
1 Year
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Wisconsin
Madison, Wisconsin, United States
Sydney Childrens Hospital
Randwick, New South Wales, Australia
AKH - Medical University of Vienna
Vienna, , Austria
St. Anna Children-Hospital, Children's Cancer Research, Wien
Vienna, , Austria
The Hospital for Sick Children
Toronto, Ontario, Canada
Rigshospitalet, København, Børneonkologisk Afsnit 5002
København Ø, , Denmark
HOP Toulouse, Pédiat, Toulouse
Toulouse, , Faroe Islands
HOP Pellegrin
Bordeaux, , France
CTR Oscar Lambret
Lille, , France
CTR Leon Berard
Lyon, , France
INS Curie
Paris, , France
INS Gustave Roussy
Villejuif, , France
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Essen AöR
Essen, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Istituto G. Gaslini
Genova, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliera Universitaria di Padova
Padua, , Italy
Osp. Pediatrico Bambin Gesù
Roma, , Italy
Erasmus MC - Sophia Kinderziekenhuis
Rotterdam, , Netherlands
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Infantil Universitario Niño Jesus
Madrid, , Spain
Birmingham Children's Hospital
Birmingham, , United Kingdom
Great Ormond Street Hospital
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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Geoerger B, Marshall LV, Nysom K, Makin G, Bouffet E, Defachelles AS, Amoroso L, Aerts I, Leblond P, Barahona P, Van-Vlerken K, Fu E, Solca F, Lorence RM, Ziegler DS. Afatinib in paediatric patients with recurrent/refractory ErbB-dysregulated tumours: Results of a phase I/expansion trial. Eur J Cancer. 2023 Jul;188:8-19. doi: 10.1016/j.ejca.2023.04.007. Epub 2023 Apr 20.
Andrade RC, Boroni M, Amazonas MK, Vargas FR. New drug candidates for osteosarcoma: Drug repurposing based on gene expression signature. Comput Biol Med. 2021 Jul;134:104470. doi: 10.1016/j.compbiomed.2021.104470. Epub 2021 May 7.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Related Info
Other Identifiers
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2014-002123-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.120
Identifier Type: -
Identifier Source: org_study_id
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