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
44339
clinical trials with a EudraCT protocol, of which
7369
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 Multicenter, Open-Label Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors
Medical condition: Non-small cell lung cancer, predominantly clear cell renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma (excluding uveal me...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10014733
Endometrial cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10060121
Squamous cell carcinoma of head and neck
PT
20.0
100000017553
10064467
Urothelial carcinoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10067946
Renal cell carcinoma
PT
20.0
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)
Full Title: A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors
Medical condition: Subjects with solid tumors of the type of colorectal cancer, pancreatic ductal adenocarcinoma, Squamous non-small cell lung cancer, non-squamous non-small cell lung cancer, any solid tumor that pro...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061451
Colorectal cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10051971
Pancreatic adenocarcinoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10079440
Non-squamous non-small cell lung cancer
LLT
20.0
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)
10064467
Urothelial carcinoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10060121
Squamous cell carcinoma of head and neck
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sponsor Name:Incyte Biosciences International Sàrl
Full Title: A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies.
Medical condition: Phase 1: advanced or metastatic cervical cancer, endometrial cancer, gastric cancer, hepatocellular carcinoma, melanoma (mucosal or cutaneous), Merkel cell carcinoma, mesothelioma, MSI-H colorectal...
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10041067
Small cell lung cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10060121
Squamous cell carcinoma of head and neck
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10014733
Endometrial cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10027407
Mesothelioma malignant
PT
20.0
100000017553
10064467
Urothelial carcinoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10073071
Hepatocellular carcinoma
PT
20.0
100000018529
10027150
Melanoma malignant
LLT
20.0
100000018548
10064025
Merkel cell carcinoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10017758
Gastric cancer
PT
20.0
100000020977
10008229
Cervical cancer
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
11.0
100000005104
10038408
Renal cell carcinomas
HLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061451
Colorectal cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10075566
Triple negative breast cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined with Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/Refractory Follicular Lymphoma
Medical condition: Relapsed/Refractory Follicular Lymphoma
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004851
10016903
Follicle centre lymphomas, follicular grade I, II, III
HLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:CZ(Trial now transitioned)GB(GB - no longer in EU/EEA)HU(Prematurely Ended)ES(Ongoing)BG(Completed)FR(Trial now transitioned)DE(Completed)PL(Trial now transitioned)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2013-002872-42
Sponsor Protocol Number: PUMA-NER-5201
Start Date*: 2014-03-25
Sponsor Name:Puma Biotechnology, Inc
Full Title: An Open-Label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR gene amplification
Medical condition: Cancer tumor with somatic human epidermal growth factor receptor mutation (EGFR, ERBB2 (HER2), ERBB3 (HER3) or EGFR gene amplification
Disease:
Version
SOC Term
Classification Code
Term
Level
16.1
100000004864
10065143
Malignant solid tumour
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:ES(Completed)IT(Completed)FI(Completed)GB(GB - no longer in EU/EEA)DK(Completed)BE(Completed)FR(Ongoing)IE(Completed)
Full Title: An Open-Label, Randomized, Phase 2 Study of Efficacy and Tolerability of ABT-869 in Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Medical condition: Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Sponsor Name:GlaxoSmithKline Research and Development Ltd
Full Title: An Open-Label, Flexible-Dose Study of Retigabine Immediate Release (IR) as Adjunctive Therapy to Specified Monotherapy Antiepileptic Treatments in Adults with Partial-Onset Seizures.
Medical condition: Epilepsy - partial-onset seizures with or without secondary generalisation
Full Title: A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyl...
Medical condition: Transthyretin (TTR) mediated familial amyloidotic cardiomyopathy (FAC)
Disease:
Version
SOC Term
Classification Code
Term
Level
18.1
10010331 - Congenital, familial and genetic disorders
Sponsor Name:Bristol-Myers Squibb International Corporation
Full Title: Phase I/II pharmacokinetic multi-tumor study of subcutaneous formulation of nivolumab monotherapy
Medical condition: The study population will include participants with 1 of the following
advanced or metastatic tumors approved for treatment with nivolumab monotherapy: non-small cell lung cancer (NSCLC); renal ce...
Disease:
Version
SOC Term
Classification Code
Term
Level
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10067946
Renal cell carcinoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10027481
Metastatic melanoma
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10073071
Hepatocellular carcinoma
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061451
Colorectal cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10064467
Urothelial carcinoma
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:PL(Ongoing)GB(GB - no longer in EU/EEA)ES(Ongoing)NL(Trial now transitioned)IT(Trial now transitioned)
Trial results:(No results available)
EudraCT Number: 2010-023550-36
Sponsor Protocol Number: H8Y-MC-HBDE
Start Date*: 2011-04-06
Sponsor Name:Eli Lilly and Company
Full Title: A Phase 3, Multicenter, Double-Blind Comparison of LY2140023 and Aripiprazole in Patients with DSM-IV-TR Schizophrenia Followed by Open-Label Treatment with LY2140023
Full Title: Phase III, randomised, double-blind, stratified comparative, placebo controlled, parallel group, multicentre study to assess the effect of deep subcutaneous injections of lanreotide Autogel 120 mg ...
Medical condition: Non functioning entero-pancreatic tumours
Disease:
Version
SOC Term
Classification Code
Term
Level
14.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer
Medical condition: relapsed or refractory small cell lung cancer (SCLC)
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: AN OPEN-LABEL, MULTICENTER EXTENSION AND LONG-TERM OBSERVATIONAL STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH- AND/OR F. HOFFMANN LA ROCHE LTD-SPONSORED ATEZOLIZUMAB STUDY
Medical condition: Cancer
(Future parent protocols may include other cancer that are not included in this section)
Disease:
Version
SOC Term
Classification Code
Term
Level
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10046721
Urothelial carcinoma bladder stage III
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10029514
Non-small cell lung cancer NOS
LLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
20.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10023400
Kidney cancer
LLT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:CZ(Completed)HU(Trial now transitioned)GB(GB - no longer in EU/EEA)ES(Ongoing)PL(Trial now transitioned)BE(Completed)FR(Trial now transitioned)NL(Ongoing)SI(Completed)PT(Completed)DE(Completed)LV(Prematurely Ended)LT(Ongoing)SK(Prematurely Ended)BG(Completed)IT(Completed)RO(Ongoing)
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