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Clinical trials for Selpercatinib

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   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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    9 result(s) found for: Selpercatinib. Displaying page 1 of 1.
    EudraCT Number: 2020-005191-35 Sponsor Protocol Number: J2G-MC-JZJX Start Date*: 2021-11-22
    Sponsor Name:Eli Lilly and Company
    Full Title: LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib following Definitive Locoregional Treatment in Participants with Stage IB-IIIA RET fusion-Positi...
    Medical condition: Adjuvant Selpercatinib following definitive locoregional treatment in male or female patients with stage IB-IIIA RET fusion 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: NL (Ongoing) AT (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) DE (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) NO (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001978-28 Sponsor Protocol Number: J2G-MC-JZJB Start Date*: 2020-01-08
    Sponsor Name:Eli Lilly and Company
    Full Title: A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients with Progressive, Advanced, Kinase Inhibitor Naïve, RET-M...
    Medical condition: Male or female patients with progressive, advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027105 Medullary thyroid cancer PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) GB (GB - no longer in EU/EEA) PL (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) NL (Ongoing) GR (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: View results
    EudraCT Number: 2019-000212-28 Sponsor Protocol Number: LOXO-RET-18036 Start Date*: 2020-04-15
    Sponsor Name:Loxo Oncology, Inc.
    Full Title: A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors
    Medical condition: Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007958 Central nervous system neoplasm PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10007959 Central nervous system neoplasm NOS LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049516 Malignant tumor LLT
    20.1 100000004852 10007960 Central nervous system neoplasms malignant NEC HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) DE (Trial now transitioned) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-001979-36 Sponsor Protocol Number: J2G-MC-JZJC Start Date*: 2020-07-14
    Sponsor Name:Eli Lilly and Company
    Full Title: LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy with or without Pembrolizumab as Initial Treatment of Advanced or...
    Medical condition: Male or female patients with advanced, treatment-naïve RET Fusion-Positive Non-Squamous 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: DE (Ongoing) CZ (Completed) GR (Trial now transitioned) FR (Trial now transitioned) PL (Completed) NL (Ongoing) GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Trial now transitioned) IT (Trial now transitioned) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2019-002319-25 Sponsor Protocol Number: LOXO-RET-18037 Start Date*: 2019-12-31
    Sponsor Name:LOXO ONCOLOGY INCORPORATED
    Full Title: A Multi-Center Expanded Access Program (EAP) for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors with Rearranged During Transfection (RET) Activation (LIBRETTO-201)
    Medical condition: Advanced or metastatic solid tumors with activating Rearranged During Transfection (RET) alterations (and other evidence of RET activation)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049280 Solid tumour LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027105 Medullary thyroid cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000800-59 Sponsor Protocol Number: LOXO-RET-17001 Start Date*: 2019-02-22
    Sponsor Name:Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company
    Full Title: A Phase 1/2 Study of Oral LOXO-292 in Patients with Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors with RET Activation (LIBRETTO-001)
    Medical condition: Male or female patients age 12 years or older with a locally advanced or metastatic solid tumor with evidence of a RET gene alteration in tumor and/or blood
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065252 Solid tumor LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027105 Medullary thyroid cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Ongoing) DK (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003974-29 Sponsor Protocol Number: D6186C00001 Start Date*: 2019-08-15
    Sponsor Name:AstraZeneca AB
    Full Title: A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy
    Medical condition: Advanced 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: SE (Trial now transitioned) NO (Trial now transitioned) DK (Completed) ES (Ongoing) NL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004771-40 Sponsor Protocol Number: ML41742 Start Date*: 2020-04-28
    Sponsor Name:Rigshospitalet
    Full Title: ProTarget A Danish Nationwide Clinical Trial on Targeted Anti-Cancer Treatment based on Genomic Profiling
    Medical condition: Eligible patients will have an advanced malignant disease for which standard treatment options are no longer available or feasible and acceptable performance status and organ function.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028997 Neoplasm malignant PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004390-41 Sponsor Protocol Number: BLU-667-1101 Start Date*: 2018-03-13
    Sponsor Name:Blueprint Medicines
    Full Title: A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients with Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors
    Medical condition: Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10066914 Thyroid tumor LLT
    20.0 100000004864 10025044 Lung cancer LLT
    21.1 100000004864 10065252 Solid tumor LLT
    21.1 100000004864 10029514 Non-small cell lung cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Completed) BE (Completed)
    Trial results: View results
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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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