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: Safety and pharmacokinetics of ODM-207 in patients with selected advanced solid tumours: an open-label, non-randomised, uncontrolled, multicentre, first-in-human study with cohort expansion
Medical condition: Advanced Solid Tumours
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
100000004864
10065143
Malignant solid tumour
LLT
Population Age: Adolescents, Under 18, Adults, Elderly
Sponsor Name:Oncoethix GmbH, a wholly owned subsidiary of Merck Sharp & Dohme Corp.
Full Title: A Phase IB Dose Exploration Trial with MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects with Selected Advanced Solid Tumors
Medical condition: NUT Midline Carcinoma
Non-Small Cell Lung Cancer
Triple-Negative Breast Cancer
Castration-Resistant Prostate Cancer
Disease:
Version
SOC Term
Classification Code
Term
Level
18.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10061873
Non-small cell lung cancer
PT
18.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10076506
Castration-resistant prostate cancer
LLT
18.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10006187
Breast cancer
PT
Population Age: Adolescents, Under 18, Adults, Elderly
Full Title: A 54 week treatment, randomized, multi center, double blind, placebo controlled study to assess the safety and efficacy of NEBIDO 1000 mg (4 ml) in elderly men with symptomatic late onset hypogonad...
Medical condition: Symptomatic late onset hypogonadism
Full Title: A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patie...
Medical condition: The medical condition under investigation is noninvasive bladder cancer in patients undergoing transurethral resection of bladder tumor/tumors.
Disease:
Version
SOC Term
Classification Code
Term
Level
14.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10005007
Bladder cancer stage 0, without cancer in situ
PT
14.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10005005
Bladder cancer recurrent
PT
14.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: Growth hormone and gonadotropin deficiency after brain injury (traumatic brain injury, subarachnoidal hemorrhage, ischemic stroke): the effects of hormone replacement on cognition,quality of life a...
Medical condition: hormonal deficiency after traumatic brain injury, subarachnoidal hemorrhage and ischemic stroke)
Full Title: An open label, Phase Ia/Ib dose finding study with BI 894999 orally administered once a day in patients with advanced malignancies, with repeated administration in patients with clinical benefit
Medical condition: Advanced, unresectable and/or metastatic solid tumours, which have failed with conventional treatment or for which no therapy of proven efficacy exists, or in patients who are not amenable to stand...
Disease:
Version
SOC Term
Classification Code
Term
Level
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)
10012820
Diffuse large B-cell lymphoma NOS
LLT
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)
10010029
Colorectal cancer NOS
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10076506
Castration-resistant prostate cancer
LLT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10078295
NUT midline carcinoma
PT
Population Age: Adolescents, Under 18, Adults, Elderly
Sponsor Name:Basilea Pharmaceutica International Ltd.
Full Title: An open-label Phase 1/2a study of oral BAL101553 in adult patients with advanced solid tumors and in adult patients with recurrent or progressive glioblastoma or high-grade glioma
Medical condition: Advanced or recurrent solid tumors, recurrent or progressive glioblastoma, or high-grade glioma
Disease:
Version
SOC Term
Classification Code
Term
Level
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)
10018336
Glioblastoma
PT
Population Age: Adults, Elderly
Gender: Male, Female
Trial protocol:GB(GB - no longer in EU/EEA)DE(Completed)BE(Completed)
Full Title: First-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (enapotamab vedotin, HuMax®-AXL-ADC) in patients with solid tumors.
Medical condition: Cancer of the ovary, cervix, endometrium, anaplastic thyroid, lung (non-small cell lung cancer [NSCLC]) or melanoma
Disease:
Version
SOC Term
Classification Code
Term
Level
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10014742
Endometrial neoplasms malignant
HLT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10008342
Cervix carcinoma
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10023774
Large cell lung cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10002240
Anaplastic thyroid cancer
PT
21.1
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10025650
Malignant melanoma
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10033128
Ovarian cancer
PT
20.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
10039491
Sarcoma
PT
21.0
10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Full Title: A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AL002 IN PARTICIPANTS WITH EARLY ALZHEIMER’S DISEASE
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• EEA CTAs: Date study was authorised to proceed • Outside EU/EEA: Date study was submitted in EudraCT