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Clinical trials for Germline development

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • 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   44335   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    25 result(s) found for: Germline development. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-002209-25 Sponsor Protocol Number: 67652000PCR3002 Start Date*: 2020-10-12
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Parti...
    Medical condition: Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Trial now transitioned) FR (Trial now transitioned) CZ (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) DE (Ongoing) PT (Trial now transitioned) BG (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002505-35 Sponsor Protocol Number: ABCSG_50 Start Date*: 2018-06-25
    Sponsor Name:ABCSG (Austrian Breast & Colorectal Cancer Study Group)
    Full Title: BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventive Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline...
    Medical condition: Prevention of breast cancer in women with a BRCA1 germline mutation
    Disease: Version SOC Term Classification Code Term Level
    21.0 10042613 - Surgical and medical procedures 10036898 Prophylaxis PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    23.0 10010331 - Congenital, familial and genetic disorders 10071980 BRCA1 gene mutation PT
    Population Age: Adults Gender: Female
    Trial protocol: AT (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000240-30 Sponsor Protocol Number: 80308 Start Date*: 2022-04-19
    Sponsor Name:Center for Experimental and Molecular Medicine, G2 (AMC)
    Full Title: The chemopreventive effect of Lithium on adenoma development in patients with familial adenomatous polyposis (FAP); a pilot study
    Medical condition: Familial adenomatous polyposis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003319-12 Sponsor Protocol Number: ICR-CTSU-2014-10046 Start Date*: 2015-03-27
    Sponsor Name:The Royal Marsden NHS Foundation Trust [...]
    1. The Royal Marsden NHS Foundation Trust
    2. The Insitute of Cancer Research
    Full Title: Window study of the PARP inhibitor rucaparib in patients with primary triple negative or BRCA1/2 related breast cancer (RIO)
    Medical condition: Primary breast cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-004780-13 Sponsor Protocol Number: CeNturIOn-2016 Start Date*: 2018-08-22
    Sponsor Name:NHS Greater Glasgow & Clyde [...]
    1. NHS Greater Glasgow & Clyde
    2. University of Glasgow
    Full Title: An open-label, randomised, phase II trial of ruCaparib combined with Nivolumab +/- Ipilimumab to augment response in homologous repair deficient patients with relapsed Ovarian, primary peritoneal a...
    Medical condition: High grade serous ovarian cancer (includes histologically identical fallopian tube and primary peritoneal cancers and high grade G3 endometrioid histological subtypes)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2014-000411-14 Sponsor Protocol Number: 6639 Start Date*: 2014-07-17
    Sponsor Name:The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological misma...
    Medical condition: Lynch Syndrome also known as HNPCC (non hereditary non polyposis colorectal cancer).
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004850 10051981 Lynch syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FI (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003548-35 Sponsor Protocol Number: MesaCAPP Start Date*: 2017-03-10
    Sponsor Name:Medical University of Vienna
    Full Title: Mesalamine for Colorectal Cancer Prevention Program in Lynch syndrome
    Medical condition: Colorectal Cancer Prevention in Lynch syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10051981 Lynch syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) NL (Prematurely Ended) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-003011-55 Sponsor Protocol Number: MesaCAPP Start Date*: 2020-07-23
    Sponsor Name:Karolinska Institute
    Full Title: Mesalamine for Colorectal Cancer Prevention Program in Lynch Syndrome
    Medical condition: Lynch Syndrome, which is increasing the risk of developing colorectal cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10051981 Lynch syndrome LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-002392-27 Sponsor Protocol Number: A5481003 Start Date*: 2009-04-06
    Sponsor Name:Pfizer Inc.
    Full Title: PHASE 1/2, OPEN-LABEL, RANDOMIZED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF LETROZOLE PLUS PD 0332991 (ORAL CDK 4/6 INHIBITOR) AND LETROZOLE SINGLE AGENT FOR THE FIRST-LINE TREATMEN...
    Medical condition: Advanced Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000020826 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IE (Completed) HU (Completed) DE (Completed) FR (Completed) IT (Completed) ES (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-005954-22 Sponsor Protocol Number: VEG108843 Start Date*: 2008-06-03
    Sponsor Name:GlaxoSmithKline Research and Development Ltd
    Full Title: A randomized, double-blind, placebo-controlled, multicenter Phase II study to compare the efficacy and tolerability of pazopanib administered in combination with exemestane versus exemestane plus p...
    Medical condition: Advanced or metastatic hormone receptor positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    9.1 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001342-21 Sponsor Protocol Number: NCTUTRK1(6840) Start Date*: 2014-09-04
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: Topical tropomysin kinase (TRK) inhibitor as a treatment for inherited CYLD defective skin tumours (TRAC)
    Medical condition: Patients with germline CYLD mutations (OMIM 605018). These include Brooke-Spiegler Syndrome, familial cylindromatosis and multiple familial trichoepitheliomas (OMIM #605041, #132700, #601606 respec...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-005392-39 Sponsor Protocol Number: 213357 Start Date*: 2022-02-25
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: OPAL Master Protocol: A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments and/or Combinations of Treatments in Participants with Ovarian Cancer (OPAL). C...
    Medical condition: Ovarian cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    24.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10084789 Homologous recombination deficiency positive advanced ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-003930-17 Sponsor Protocol Number: 1407-GUCG Start Date*: 2015-10-05
    Sponsor Name:European Organisation for Research and Treatment of Cancer (EORTC)
    Full Title: A RANDOMIZED PHASE III TRIAL COMPARING CONVENTIONAL-DOSE CHEMOTHERAPY USING PACLITAXEL, IFOSFAMIDE, AND CISPLATIN (TIP) WITH HIGH-DOSE CHEMOTHERAPY USING MOBILIZING PACLITAXEL PLUS IFOSFAMIDE FOLLO...
    Medical condition: progressive or recurrent germ cell tumor (measurable or non-measurable)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10043338 Testicular malignant germ cell tumor NOS LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: BE (Trial now transitioned) DK (Trial now transitioned) IE (Trial now transitioned) FR (Trial now transitioned) NL (Trial now transitioned) SI (Completed) ES (Ongoing) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-004299-38 Sponsor Protocol Number: ESPAC-4Version:7Date:21/07/2011 Start Date*: 2008-09-17
    Sponsor Name:The University of Liverpool [...]
    1. The University of Liverpool
    2. The Royal Liverpool and Broadgreen University Hospital NHS Trust
    Full Title: European Study Group for Pancreatic Cancer - Trial 4. Combination versus single agent chemotherapy in resectable pancreatic ductal and peri-ampullary cancers.
    Medical condition: Resectable pancreatic or peri-ampullary cancers
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10033602 Pancreatic adenocarcinoma resectable LLT
    14.1 100000004864 10034446 Periampullary carcinoma resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Restarted) FI (Prematurely Ended) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-005725-29 Sponsor Protocol Number: EGF110656 Start Date*: 2008-05-09
    Sponsor Name:GlaxoSmithKline Research and Development
    Full Title: A Phase III Study of ErbB2 Positive Advanced or Metastatic Gastric or Esophageal Or Gastroesophageal Junction Adenocarcinoma Treated with Capecitabine Plus Oxaliplatin with or without Lapatinib
    Medical condition: Subjects with ErbB2-positive advanced or metastatic gastric or oesophageal or gastro-oesophageal junction adenocarcinoma.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001150 Adenocarcinoma gastric LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) IT (Completed) NL (Ongoing) HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001935-12 Sponsor Protocol Number: AIEOP-BFM-ALL-2017 Start Date*: 2018-07-02
    Sponsor Name:Universitätsklinikum Schleswig-Holstein, Campus Kiel
    Full Title: AIEOP-BFM ALL 2017 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
    Medical condition: acute lymphoblastic leukemia in children and adolescents <18 years of age
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned) IT (Trial now transitioned) SK (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-002472-34 Sponsor Protocol Number: EGF109462 Start Date*: 2007-08-06
    Sponsor Name:GlaxoSmithKline Research and Development Limited
    Full Title: A single-arm, two-stage Phase II study of Lapatinib and Pemetrexed in the second line treatment of advanced or metastatic Non-Small Cell Lung Cancer
    Medical condition: Patients with advanced or metatstatic Non-Small Cell Lung Cancer who have received one prior platinum containing chemotherapy regimen
    Disease: Version SOC Term Classification Code Term Level
    9.1 10061873 Non-small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003452-21 Sponsor Protocol Number: BRF117277 Start Date*: 2014-01-27
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib plus Trametinib in Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain.
    Medical condition: Subjects with BRAF Mutation-Positive Melanoma that has Metastasized to the Brain
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001271-16 Sponsor Protocol Number: AGO-OVAR28 Start Date*: 2022-08-01
    Sponsor Name:AGO Research GmbH
    Full Title: Niraparib vs Niraparib in combination with Bevacizumab in patients with carboplatinum-taxane based chemotherapy in advanced ovarian cancer (A multicentre randomised phase III trial)
    Medical condition: Patients with newly diagnosed, histologically confirmed, primary advanced invasive high grade epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer, FIGO stage III/IV (except FIGO ...
    Disease: Version SOC Term Classification Code Term Level
    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) 10016180 Fallopian tube cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052171 Peritoneal carcinoma LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-005933-12 Sponsor Protocol Number: E7080-G000-201 Start Date*: 2009-10-29
    Sponsor Name:Eisai Limited
    Full Title: Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified...
    Medical condition: Medullary thyroid cancer [MTC] or radioiodine (131*I) refractory/resistant differentiated thyroid cancer[DTC]: Determine the pharmacokinetic (PK) profile and the pharmacokinetic/pharmacodynamic (PK...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065252 Solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) GB (Completed) IT (Completed)
    Trial results: View results
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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