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Clinical trials for Germline mutations

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
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    • 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   44336   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 ).  
     
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    65 result(s) found for: Germline mutations. Displaying page 1 of 4.
    1  2  3  4  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: 2020-004770-22 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: 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: 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: 2015-000298-11 Sponsor Protocol Number: ISS22810078 Start Date*: 2015-09-02
    Sponsor Name:AZIENDA OSPEDALIERA "ISTITUTI OSPITALIERI" DI CREMONA
    Full Title: A phase II, open label, controlled study of olaparib in locally advanced ER, PgR and HER2 negative (Triple Negative) and in locally advanced germline BRCA mutation-positive breast cancer patients: ...
    Medical condition: Locally advanced breast cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10072740 Locally advanced breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    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: 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: 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: 2020-000109-10 Sponsor Protocol Number: UNITO-001/2020 Start Date*: 2020-09-30
    Sponsor Name:DIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO
    Full Title: A Phase II, Open-Label, Single Arm, prospective, multicenter study of niraparib plus dostarlimab in patients with advanced non-small cell lung cancer and malignant pleural mesothelioma, positive fo...
    Medical condition: patients with advanced non-small cell lung cancer and malignant pleural mesothelioma, positive for PD-L1 expression and germ or somatic mutations in DNA damage repair genes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062042 Lung neoplasm PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10045155 Tumor of pleura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    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: 2011-002099-18 Sponsor Protocol Number: Veli-BRCA Start Date*: 2011-09-02
    Sponsor Name:Vejle Hospital
    Full Title: Veliparib (ABT888) Monotherapy for Patients with BRCA germline mutation and Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer
    Medical condition: BRCA germline mutational and Platinum-Resistant or Partially Platinum-Sensitive Recurrent Epithelial Ovarian Cancer.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033130 Ovarian cancer NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2017-001054-34 Sponsor Protocol Number: D0816C00018 Start Date*: 2018-01-11
    Sponsor Name:AstraZeneca AB
    Full Title: LUCY - Lynparza Breast Cancer Real-World Utility, Clinical Effectiveness and Safety Study A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-...
    Medical condition: Metastatic 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: DE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) HU (Completed) FR (Completed) PL (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    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: 2015-005838-22 Sponsor Protocol Number: CLIO Start Date*: 2016-07-22
    Sponsor Name:UZLeuven
    Full Title: Circulating tumor DNA guiding (Olaparib) Lynparza® treatment in Ovarian Cancer (CLIO). Establishing the value of a ctDNA-based HRD assay for predicting olaparib response in women with relapsed ovar...
    Medical condition: platinum-sensitive and platinum-resistant relapsed ovarian cancer
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001482-57 Sponsor Protocol Number: SAKK_41/13-Aspirin Start Date*: 2016-09-19
    Sponsor Name:SAKK Swiss Group for Clinical Cancer Research
    Full Title: Adjuvant aspirin treatment in PIK3CA mutated colon cancer patients. A randomized, double-blinded, placebo-controlled, phase III trial
    Medical condition: PIK3CA mutated colon cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002573-35 Sponsor Protocol Number: OZM-058 Start Date*: 2019-08-30
    Sponsor Name:University Health Network, Toronto
    Full Title: A Phase II, Open-Label, Randomized, Multi-Centre Study, of Neoadjuvant Olaparib in Patients with Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian tube Cancer.
    Medical condition: Platinum Sensitive Recurrent High Grade Serous Ovarian/Primary Peritoneal or Fallopian tube 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: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002913-12 Sponsor Protocol Number: M12-895 Start Date*: 2012-05-15
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplati...
    Medical condition: BRCA1 or BRCA2 mutation metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) DK (Completed) SK (Completed) FI (Completed) SE (Completed) BE (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-003612-45 Sponsor Protocol Number: A9001502 Start Date*: 2019-09-06
    Sponsor Name:Pfizer Inc.
    Full Title: TREATMENT RESISTANCE FOLLOWING ANTI-CANCER THERAPIES (TRANSLATE)
    Medical condition: Cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
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