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
44334
clinical trials with a EudraCT protocol, of which
7366
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: A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma
Medical condition: Relapsed or refractory solid tumors or lymphoma in children
Neuroblastoma
Osteosarcoma
Rhabdomyosarcoma
Ewing sarcoma
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10025310
Lymphoma
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065147
Malignant solid tumor
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029260
Neuroblastoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10031291
Osteosarcoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10039022
Rhabdomyosarcoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10015560
Ewing's sarcoma
PT
Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults
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• EEA CTAs: Date study was authorised to proceed • Outside EU/EEA: Date study was submitted in EudraCT