interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development
EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
Clinical Trials Information System (CTIS).
The EU Clinical Trials Register currently displays
44154
clinical trials with a EudraCT protocol, of which
7326
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see
Frequently Asked Questions ).
Full Title: An international prospective umbrella trial for children with atypical teratoid/rhabdoid tumours (ATRT) including A randomized phase III study evaluating the non-inferiority of three courses of hig...
Medical condition: atypical teratoid/rhabdoid tumours (ATRT)
Disease:
Population Age: Newborns, Infants and toddlers, Children, Under 18
Gender: Male, Female
Trial protocol:DE(Ongoing)NO(Trial now transitioned)NL(Trial now transitioned)DK(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2015-002468-18
Sponsor Protocol Number: EZH-102
Start Date*: 2016-02-19
Sponsor Name:Epizyme, Inc.
Full Title: A Phase 1 Study of the EZH2 Inhibitor Tazemetostat in Pediatric Subjects with Relapsed or Refractory INI1-Negative Tumors or Synovial Sarcoma
Medical condition: Atypical teratoid rhabdoid tumor (ATRT), Malignant rhabdoid tumor (MRT), Rhabdoid tumor of kidney (RTK), selected tumors with rhabdoid features.
Epithelioid sarcoma, Epithelioid malignant peripher...
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10064886
Renal medullary carcinoma
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065870
Atypical teratoid/rhabdoid tumor of CNS
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10073134
Extraskeletal myxoid chondrosarcoma
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10073335
Rhabdoid tumor
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10074121
Rhabdoid tumor of the kidney
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10042863
Synovial sarcoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10015100
Epithelioid sarcomas
HLT
Population Age: Infants and toddlers, Children, Adolescents, Under 18
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)DK(Completed)DE(Completed)NL(Completed)IT(Completed)
Sponsor Name:Medizinische Universität Wien, Universitätsklinik für Kinder- und Jugendheilkunde
Full Title: A Phase II study of metronomic and targeted anti-angiogenesis therapy
for children with recurrent/progressive medulloblastoma, ependymoma and ATRT
Medical condition: Recurrent/progressive medulloblastoma, ependymoma and ATRT
Disease:
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:AT(Ongoing)SE(Restarted)CZ(Trial now transitioned)DK(Trial now transitioned)NO(Trial now transitioned)ES(Ongoing)
Trial results:(No results available)
EudraCT Number: 2018-000127-14
Sponsor Protocol Number: NCT-2017-0516
Start Date*: Information not available in EudraCT
Sponsor Name:Heidelberg University Hospital
Full Title: INFORM2 exploratory multinational phase I/II combination study of Nivolumab and Entinostat in children and adolescents with refractory high-risk malignancies
Medical condition: This trial investigates a novel combination treatment regimen using immune checkpoint inhibition and epigenetic therapy in children with relapsed/refractory/progressive high-risk solid tumors or CN...
Disease:
Population Age: Children, Adolescents, Under 18, Adults
Full Title: A PHASE I/II, MULTICENTER, OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF COBIMETINIB IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH PREVIOUSLY TREATED SOLID TUMORS
Medical condition: Solid Tumors
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000020962
10065252
Solid tumor
LLT
Population Age: Children, Adolescents, Under 18, Adults
Gender: Male, Female
Trial protocol:NL(Completed)IE(Completed)DK(Completed)GB(GB - no longer in EU/EEA)DE(Completed)ES(Completed)IT(Completed)FR(Completed)
Full Title: A Phase II, Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
Medical condition: Cohort 1: Rhabdoid tumors (malignant rhabdoid tumors, rhabdoid tumors of the kidney, atypical teratoid rhabdoid tumors, and selected tumors
Cohort 2: Relapsed/refractory synovial sarcoma with SS18...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10007284
Carcinoma
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10064886
Renal medullary carcinoma
LLT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10073134
Extraskeletal myxoid chondrosarcoma
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10026667
Malignant peripheral nerve sheath tumor
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10073335
Rhabdoid tumor
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10042863
Synovial sarcoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10015100
Epithelioid sarcomas
HLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)DE(Completed)BE(Completed)FR(Completed)IT(Completed)
Trial results:(No results available)
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• EEA CTAs: Date study was authorised to proceed • Outside EU/EEA: Date study was submitted in EudraCT