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Clinical trials for Germline

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    173 result(s) found for: Germline. Displaying page 1 of 9.
    1  2  3  4  5  6  7  8  9  Next»
    EudraCT Number: 2018-002966-37 Sponsor Protocol Number: 1-2018BSMO Start Date*: 2019-01-23
    Sponsor Name:Belgian Society of Medical Oncology
    Full Title: Efficacy of Olaparib in advanced cancers occurring in patients with germline mutations or somatic tumor mutations in homologous recombination genes.
    Medical condition: Advanced cancer patients that have a germline mutation or a somatic mutation in their tumor. Prostate and ovarian cancer patients and breast cancer patients who carry a BRCA1/2 mutation will be exc...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000155-41 Sponsor Protocol Number: 1 Start Date*: 2019-01-10
    Sponsor Name:Department of Medical and Clinical Genetics, University of Helsinki
    Full Title: The effect of vitamin C on the gene methylation load in patients with TET2 mutations
    Medical condition: germline TET-2 gene mutation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    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: 2020-004770-22 Sponsor Protocol Number: TAS-117-201 Start Date*: 2021-04-01
    Sponsor Name:Taiho Oncology, Inc.
    Full Title: A Phase 2 Study of TAS-117 in Patients with Advanced Solid Tumors Harboring Germline PTEN Inactivating Mutations
    Medical condition: Advanced Solid Tumors Harboring Germline PTEN Inactivating Mutations
    Disease: Version SOC Term Classification Code Term Level
    23.0 10010331 - Congenital, familial and genetic disorders 10071986 PTEN gene mutation PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) AT (Prematurely Ended) IT (Prematurely Ended) ES (Prematurely Ended) SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-002767-17 Sponsor Protocol Number: D0816C00020 Start Date*: 2017-12-14
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed non-Germline BRCA Mutated Ovarian Cancer Patients who are in Complete or Pa...
    Medical condition: Non Germline BRCA Mutated 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
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Completed) SI (Completed) BG (Completed) GB (GB - no longer in EU/EEA) NL (Completed) ES (Completed) BE (Completed) AT (Completed) SE (Completed) PT (Completed) NO (Completed) DK (Completed) FI (Completed) PL (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    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: 2016-001407-23 Sponsor Protocol Number: GEICAM/2015-06 Start Date*: 2017-01-05
    Sponsor Name:GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
    Full Title: A Phase II Clinical Trial to analyse Olaparib Response in patients with BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer (COMETA-Breast study).
    Medical condition: Patients with advanced triple negative breast cancer (TNBC) with BRCA1 and/or BRCA2 promoter methylation assessed in DNA from metastatic lesions and absence of BRCA1 and 2 germline mutations.
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2019-003702-27 Sponsor Protocol Number: P170929J Start Date*: 2021-04-12
    Sponsor Name:Assistance Publique – Hôpitaux de Paris (AP-HP)
    Full Title: Phase II clinical trial aiming at investigating the effect of a PARP-inhibitor on advanced metastatic breast cancer in germline PALB2 mutations carriers
    Medical condition: Patients with HER2 positive disease.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-000684-85 Sponsor Protocol Number: PR-30-5010-C Start Date*: 2014-01-14
    Sponsor Name:TESARO UK Limited, (c/o Sisec Limited) [...]
    1. TESARO UK Limited, (c/o Sisec Limited)
    2. TESARO Inc
    Full Title: A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients
    Medical condition: HER2 negative, BRCA germline mutated breast cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IS (Completed) HU (Completed) BE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) ES (Ongoing) PT (Completed) IT (Completed) FR (Completed) PL (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2018-000617-20 Sponsor Protocol Number: MITO31 Start Date*: 2018-11-14
    Sponsor Name:ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
    Full Title: A phase II trial of Olaparib in patients with recurrent ovarian cancer wild type for germline and somatic BRCA 1 and 2 genes: The MITO 31 transalational study.
    Medical condition: patients with recurrent ovarian cancer wild type for germline and somatic BRCA 1 and 2 genes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-002716-28 Sponsor Protocol Number: 673-301 Start Date*: 2014-05-03
    Sponsor Name:Medivation, Inc.
    Full Title: A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of Talazoparib (BMN 673) versus Physician’s Choice in Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic ...
    Medical condition: Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) IT (Completed) IE (Completed) FR (Completed) ES (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-001940-25 Sponsor Protocol Number: IFG-05-2019 Start Date*: 2021-08-25
    Sponsor Name:Institut für Frauengesundheit GmbH
    Full Title: A PHASE II OPEN-LABEL STUDY FOR THE COMPREHENSIVE ANALYSIS OF PREDICTORS OF THE TREATMENT WITH PEMBROLIZUMAB AND OLAPARIB IN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2 NEGATIVE BREAST CANCER AND...
    Medical condition: patients with unresectable or metastatic HER2 negative breast cancer and a deleterious germline mutation in BRCA 1/2, ATM, BARD1, CHEK2, FANCC, PALB2, RAD51C, RAD51D, SLX4, XRCC2 or a homologous re...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057654 Breast cancer female PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061020 Breast cancer male PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-003076-12 Sponsor Protocol Number: 673-201 Start Date*: 2014-07-30
    Sponsor Name:Medivation, Inc.
    Full Title: A Phase 2, 2-Stage. 2-Cohort Study of Talazoparib (BMN 673) Administered to Germline BRCA Mutation Subjects with Locally Advanced and/or Metastatic Breast Cancer
    Medical condition: Locally advanced and/or metastatic breast cancer with germline BRCA1 or BRCA2 mutations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005584-33 Sponsor Protocol Number: KUN2009 Start Date*: 2010-02-09
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: Dendritic cell vaccination in patients with Lynch Syndrome or colorectal cancer with MSI
    Medical condition: In this study our primary objective is to induce or enhance an immune response to tumor antigens in Lynch syndrome mutation carriers (with and without colorectal adenomas or carcinomas) and patient...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003947-51 Sponsor Protocol Number: M14POS Start Date*: 2014-10-06
    Sponsor Name:NKI-AVL
    Full Title: Phase I/prospective randomized phase II trial Of the Safety and Efficacy of tamoxifen in combination with the Isoform selective Pi3K inhibitor GDC-0032 compared with tamoxifen alONe in hormone rece...
    Medical condition: Hormone receptor positive metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Temporarily Halted) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003083-98 Sponsor Protocol Number: EP0057-201 Start Date*: 2020-12-16
    Sponsor Name:Ellipses Pharma Limited
    Full Title: A Phase 2 study to evaluate the safety and efficacy of EP0057 in combination with Olaparib in advanced ovarian cancer patients who have: Cohort 1 – platinum resistant disease and are PARP inhibitor...
    Medical condition: Advanced ovarian cancer patients who have: Cohort 1 – platinum resistant disease and are PARP inhibitor naïve; Cohort 2 – had at least 2 prior lines of therapy which must include at least 1 line ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA) HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-003832-57 Sponsor Protocol Number: UC-0140/1812 Start Date*: 2019-02-28
    Sponsor Name:UNICANCER
    Full Title: DOLAF- An international multicenter phase I/II trial of Durvalumab (MEDI4736) plus OLAparib plus Fulvestrant in metastatic or locally advanced ER-positive, HER2-negative breast cancer patients sele...
    Medical condition: ER-positive and HER2-negative metastatic or locally advanced breast cancer with either a germline or somatic BRCA mutation, or a deleterious alteration of other genes involved in homologous recombi...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10072740 Locally advanced breast cancer LLT
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    20.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-004868-30 Sponsor Protocol Number: PNET5MB Start Date*: 2013-10-31
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: AN INTERNATIONAL PROSPECTIVE TRIAL ON MEDULLOBLASTOMA (MB) IN CHILDREN OLDER THAN 3 TO 5 YEARS WITH WNT BIOLOGICAL PROFILE (PNET 5 MB – LR and PNET 5 MB – WNT-HR), AVERAGE-RISK BIOLOGICAL PROFILE (...
    Medical condition: Children with medulloblastoma. Medulloblastoma is a highly cellular malignant embryonal neoplasm.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027107 Medulloblastoma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned) FI (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) AT (Trial now transitioned) NO (Completed) CZ (Trial now transitioned) NL (Trial now transitioned) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003839-30 Sponsor Protocol Number: D081CC00006 Start Date*: 2014-06-16
    Sponsor Name:AstraZeneca AB
    Full Title: A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germl...
    Medical condition: Adjuvant breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006187 Breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) NL (Ongoing) AT (Trial now transitioned) IS (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004682-40 Sponsor Protocol Number: CBYL719K12301 Start Date*: 2021-06-16
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-O: A Phase III, multi-center, randomized (1:1), open-label, active-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with olaparib as compared to single a...
    Medical condition: Platinum-resistant or refractory, high-grade serous ovarian cancer with no germline BRCA mutation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033130 Ovarian cancer NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) PT (Completed) FI (Trial now transitioned) CZ (Completed) DK (Completed) SK (Completed) FR (Completed) NL (Completed) ES (Ongoing) DE (Trial now transitioned) IT (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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