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
44341
clinical trials with a EudraCT protocol, of which
7370
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: Secured access to nivolumab for adult patients with selected rare cancer types
Medical condition: Unresectable locally advanced or metastatic, non-clear cell renal cell carcinoma, rare head and neck cancer, rare skin cancer, MSI-nonCRC or penile cancer, which is resistant or refractory to stand...
Sponsor Name:AZIENDA SOCIO SANITARIA TERRITORIALE DEGLI SPEDALI CIVILI DI BRESCIA
Full Title: P-ACC Trial - Phase II, single arm, multicenter, open-label study of PARP inhibitors + cisplatin in Recurrent and/or Metastatic Adenoid Cystic Carcinoma
Medical condition: patients with recurrent and/or Metastatic Adenoid Cystic Carcinoma
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10053231
Adenoid cystic carcinoma
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10073370
Adenoid cystic carcinoma of salivary gland
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10053231
Adenoid cystic carcinoma
PT
24.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A Phase 2 Open-Label Trial to Evaluate Enoblituzumab in Combination with Retifanlimab or Tebotelimab in the First-Line Treatment of Patients with Recurrent or Metastatic Squamous Cell Carcinoma of ...
Medical condition: Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduct...
Full Title: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti–B7-H3 Antibody Drug Conjugate) Alone and in Combination with MGA012 (Anti–PD-1 Antibody) in Patients with Advanced Sol...
Medical condition: Advanced Solid Tumors
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10067821
Head and neck cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10036921
Prostate carcinoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10075566
Triple negative breast cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065147
Malignant solid tumor
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065252
Solid tumor
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sponsor Name:Cambridge University Hospitals NHS Foundation Trust
Full Title: A Multi-Centre Prospective Controlled Trial Comparing Calcineurin Inhibitor Monotherapy With Sirolimus Monotherapy in Hepatitis C Infected Patients with Hepatic Fibrosis Following Liver Transplanta...
Medical condition: Patients who have undergone liver transplantation and are infected with Hepatitis C virus.
Full Title: Optimizing DMARD-therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome
Medical condition: Sjogren's Syndrome
Disease:
Version
SOC Term
Classification Code
Term
Level
18.0
10028395 - Musculoskeletal and connective tissue disorders
10040766
Sjogren's disease
LLT
18.0
10028395 - Musculoskeletal and connective tissue disorders
10040767
Sjogren's syndrome
PT
18.0
10028395 - Musculoskeletal and connective tissue disorders
10042846
Syndrome Sjogren's
LLT
18.0
10028395 - Musculoskeletal and connective tissue disorders
Full Title: A phase III, randomized, multinational study, double-blinded for the immunogenicity and consistency evaluation of 3 Hib-MenCY-TT vaccine lots and single-blinded and controlled for the evaluation of...
Medical condition: Invasive disease caused by Haemophilus type b and Neisseria meningitidis serogroups C and Y
Sponsor Name:FONDAZIONE IRCCS "ISTITUTO NAZIONALE DEI TUMORI"
Full Title: A multicenter randomized trial to evaluate the efficacy of fentanyl pectin nasal spray (FPNS) versus Physician Choice (PC) - Usual Care (UC), in reducing incidental predictable breakthrough pain (I...
Medical condition: Patients with head and neck cancer .
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10067821
Head and neck cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sponsor Name:Takeda Development Center Americas, Inc. (TDC Americas)
Full Title: An Open-label, Dose Escalation, Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-676 as a Single Agent and in Combination With Pembrolizumab in Ad...
Medical condition: Solid Neoplasms
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065252
Solid tumor
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:AT(Trial now transitioned)PL(Trial now transitioned)BE(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2016-004289-25
Sponsor Protocol Number: INCB24360-206
Start Date*: 2017-07-14
Sponsor Name:Incyte Corporation
Full Title: A Phase 1/2 Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Azacitidine in Combination With Pembrolizumab and Epacadostat in Subjects With Advanced S...
Medical condition: Subjects With Advanced Solid Tumors and Previously Treated Stage IIIB or Stage IV Non–Small Cell Lung Cancer and Stage IV Microsatellite Stable Colorectal Cancer
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10010035
Colorectal cancer stage IV
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10048683
Advanced cancer
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029522
Non-small cell lung cancer stage IV
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029521
Non-small cell lung cancer stage IIIB
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety, Tolerability, and Efficacy Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Subjects With Advanced or Metastatic
Maligna...
Medical condition: Phase 1 (Dose Escalation): Advanced or metastatic solid tumors.
Phase 2 (Dose Expansion): Advanced or metastatic non–small cell lung cancer (NSCLC), unresectable or metastatic melanoma (MEL) and r...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029515
Non-small cell lung cancer recurrent
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029522
Non-small cell lung cancer stage IV
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10050017
Lung cancer metastatic
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10027480
Metastatic malignant melanoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10027150
Melanoma malignant
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10027481
Metastatic melanoma
LLT
20.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10065143
Malignant solid tumour
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10067821
Head and neck cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo-Controlled Study of Inebilizumab Efficacy and Safety in IgG4 Related Disease
Medical condition: Immunoglobulin G4-related disease (IgG4-RD)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10028395 - Musculoskeletal and connective tissue disorders
10077271
Immunoglobulin G4 related disease
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:DE(Trial now transitioned)PL(Trial now transitioned)FR(Trial now transitioned)HU(Completed)NL(Trial now transitioned)IT(Trial now transitioned)SE(Completed)
Trial results:(No results available)
EudraCT Number: 2006-004111-22
Sponsor Protocol Number: CSOM230B2305
Start Date*: 2007-01-05
Sponsor Name:Novartis Pharma Services AG
Full Title: A randomized, double-blind study to assess the safety and efficacy of different dose levels of Pasireotide (SOM230) s.c. over a 6 month treatment period in patients with de novo, persistent or recu...
Medical condition: Cushing’s disease is rare disease that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. The elevated ACTH secreted by these tumors stimulates the adrenal glands to pr...
Full Title: Blinded, randomised, controlled, multicenter study to evaluate the clinical efficacy against varicella disease of GlaxoSmithKline Biologicals’ live attenuated varicella vaccine (Varilrix) given on ...
Medical condition: Healthy children between 12-22 months (including the day before the 23-month birthday) of age at the time of vaccination with no history of measles, mumps, rubella and varicella diseases/vaccination.
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