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Clinical trials for De novo 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
  • 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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    40 result(s) found for: De novo mutations. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2019-002869-35 Sponsor Protocol Number: CAPLAND Start Date*: 2020-03-10
    Sponsor Name:FONDAZIONE RICERCA TRASLAZIONALE (FORT)
    Full Title: A randomized, non-comparative, phase II study investigating the best epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) sequence in advanced or metastatic non-small-cell lung can...
    Medical condition: Advanced or metastatic untreated EGFR mutation positive NSCLC
    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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000248-23 Sponsor Protocol Number: C3441052 Start Date*: 2021-10-22
    Sponsor Name:Pfizer Inc.
    Full Title: TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
    Medical condition: Metastatic Castration-sensitive Prostate Cancer
    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: CZ (Trial now transitioned) DE (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned) SK (Trial now transitioned) FI (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing) BG (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    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
    EudraCT Number: 2007-005806-29 Sponsor Protocol Number: AKH-AML-0108 Start Date*: 2008-05-23
    Sponsor Name:Medical University of Vienna, Dep. of Internal Medicine I, division of Hematology & Hemostaseology
    Full Title: Evaluation of Efficacy and Toxicity of Intensified Consolidation Therapy in AML Patients ≥60 Years
    Medical condition: Acute myeloid leukemia (AML), de novo, FAB classification other than M3 or WHO classification other than APL t(15,17), > 60 years, abesence of any other antededent hematologic disease of >8 months,...
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003295-31 Sponsor Protocol Number: C3441021 Start Date*: 2019-03-15
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of Talazoparib With Enzalutamide In Metastatic Castration-resistant Prostate Cancer
    Medical condition: Metastatic Castration-resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults Gender: Male
    Trial protocol: SE (Trial now transitioned) DE (Trial now transitioned) NO (Trial now transitioned) GB (GB - no longer in EU/EEA) CZ (Trial now transitioned) FI (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) PL (Trial now transitioned) HU (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003648-22 Sponsor Protocol Number: SAKK_2118 Start Date*: 2020-02-26
    Sponsor Name:SAKK
    Full Title: Ribociclib-endocrine combination therapy versus chemotherapy as 1st line treatment in patients with visceral metastatic breast cancer. A multicenter, randomized phase III trial.
    Medical condition: Histologically or cytologically confirmed diagnosis of HR-positive, HER2-negative advanced stage breast cancer with measurable visceral metastases .
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    20.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-000826-31 Sponsor Protocol Number: NN7999-3774 Start Date*: 2012-08-24
    Sponsor Name:Novo Nordisk
    Full Title: Safety, Efficacy and Pharmacokinetics of NNC-0156- 0000-0009 (N9-GP) in Previously Treated Children with Haemophilia B
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-003024-33 Sponsor Protocol Number: D5162C00048 Start Date*: 2023-01-13
    Sponsor Name:AstraZeneca AB
    Full Title: An Open-label, Single-arm, Phase II, Multinational, Multicentre Study to Assess the Efficacy and Safety of 5 Years of Osimertinib in Participants with Epidermal Growth Factor Receptor Mutation-Posi...
    Medical condition: Non-Small Cell Lung Cancer
    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
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-020613-91 Sponsor Protocol Number: MC-PEGASP.1/adults Start Date*: 2010-11-18
    Sponsor Name:medac Gesellschaft für klinische Spezialpräparate mbH
    Full Title: A randomized, multi-centre, parallel-group, open label, Oncaspar® controlled dose ranging trial of three doses of pegylated recombinant asparaginase in adult patients with newly diagnosed acute lym...
    Medical condition: Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2006-002743-89 Sponsor Protocol Number: S0106 Start Date*: 2007-04-10
    Sponsor Name:Southwest Oncology Group (SWOG)
    Full Title: A PHASE III STUDY OF THE ADDITION OF GEMTUZUMAB OZOGAMICIN (MYLOTARG®) DURING INDUCTION THERAPY VERSUS STANDARD INDUCTION WITH DAUNOMYCIN AND CYTOSINE ARABINOSIDE FOLLOWED BY CONSOLIDATION AND SUBS...
    Medical condition: Previously untreated de novo acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10000886 Acute myeloid leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-002036-32 Sponsor Protocol Number: C3441006(MDV3800-06) Start Date*: 2016-12-05
    Sponsor Name:Pfizer Inc.
    Full Title: TALAPRO 1: A PHASE 2, OPEN LABEL, RESPONSE RATE STUDY OF TALAZOPARIB IN MEN WITH DNA REPAIR DEFECTS AND METASTATIC CASTRATION RESISTANT PROSTATE CANCER WHO PREVIOUSLY RECEIVED TAXANE BASED CHEMOTHE...
    Medical condition: Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and...
    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
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076506 Castration-resistant prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) NL (Completed) ES (Ongoing) FR (Completed) BE (Completed) GB (Completed) AT (Completed) DK (Prematurely Ended) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023072-17 Sponsor Protocol Number: NN7999-3775 Start Date*: Information not available in EudraCT
    Sponsor Name:Novo Nordisk A/S
    Full Title: Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure in Patients with Haemophilia B
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    12.1 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: FR (Ongoing) GB (Completed) NL (Completed) DE (Completed) IT (Completed) ES (Completed) AT (Completed) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004382-13 Sponsor Protocol Number: DANCE Start Date*: 2019-11-28
    Sponsor Name:IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    Full Title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CEMDISIRAN (ALN-CC5) FOLLOWING WITHDRAWAL OF CHRONIC ECULIZUMAB THERAPY IN PATIENTS WITH ATYP...
    Medical condition: Atypical Hemolytic Uremic Syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10019515 Hemolytic uremic syndrome LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006300-27 Sponsor Protocol Number: MC-ASP.6/INF Start Date*: 2009-08-12
    Sponsor Name:medac Gesellschaft für klinische Spezialpräparate mbH
    Full Title: Efficacy and safety of recombinant asparaginase in infants (< 1 year) with previously untreated acute lymphoblastic leukaemia - Phase II Clinical Trial -
    Medical condition: Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000699-24 Sponsor Protocol Number: PHRC2010-03 Start Date*: 2014-10-02
    Sponsor Name:CHU Angers-DAMR
    Full Title: Essai de phase 3 visant à améliorer la survie globale des LAM de l’adulte de 18 à 60 ans en comparant l’idarubicine à forte dose à la daunorubicine à l’induction, la cytarabine à haute-dose et à do...
    Medical condition: Leucémie aiguë myéloïde
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-003180-31 Sponsor Protocol Number: MC-ASP.5/ALL Start Date*: 2008-07-29
    Sponsor Name:medac GmbH
    Full Title: Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia
    Medical condition: Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10000844 Acute lymphoblastic leukaemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-003315-35 Sponsor Protocol Number: B7461006 Start Date*: 2017-08-01
    Sponsor Name:Pfizer Inc,
    Full Title: A Phase 3, randomized, open-label study of lorlatinib (PF-06463922) monotherapy versus crizotinib monotherapy in the first-line treatment of patients with advanced ALK-positive non-small cell lung ...
    Medical condition: Advanced ALK positive non small cell lung cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) DK (Prematurely Ended) CZ (Trial now transitioned) BE (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002094-18 Sponsor Protocol Number: REL-AML001/2017 Start Date*: 2018-05-18
    Sponsor Name:AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA
    Full Title: Prospective evaluation of a continuation therapy with Midostaurin in adult patients with core-binding factor leukemia and integrated genetic analysis: a multi-center phase II study
    Medical condition: Acute Myeloid Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001180-23 Sponsor Protocol Number: 1042-CDD-3001 Start Date*: 2018-12-06
    Sponsor Name:Marinus Pharmaceuticals, Inc.
    Full Title: A Double-blind, Randomized, Placebo-controlled Trial of Adjunctive Ganaxolone Treatment in Children and Young Adults with Cyclin-dependent Kinase-like 5 (CDKL5) Deficiency Disorder (CDD) Followed b...
    Medical condition: Treatment of seizures in children and young adults with genetically confirmed cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10032062 Other forms of epilepsy, with intractable epilepsy LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed) FR (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004860-36 Sponsor Protocol Number: DEXAML-02 Start Date*: 2018-05-15
    Sponsor Name:French Innovative Leukemia Organization (FILO)
    Full Title: A phase II study of dexamethasone added to induction and post-remission therapy in older patients with newly diagnosed AML. A French Innovative Leukemia Organization (FILO) study.
    Medical condition: Elderly patients > 60 years with untreated acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000835 Acute leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
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