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Clinical trials for Avapritinib

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   44334   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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    6 result(s) found for: Avapritinib. Displaying page 1 of 1.
    EudraCT Number: 2020-005234-15 Sponsor Protocol Number: BLU-285-3101 Start Date*: Information not available in EudraCT
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: A Phase 1/2, Single-arm Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of Avapritinib in Pediatric Patients with Solid Tumors Dependent on KIT or PDGFRA Signaling
    Medical condition: Solid Tumors Dependent on KIT or PDGFRA Signaling
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) FR (Trial now transitioned) AT (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000588-99 Sponsor Protocol Number: BLU-285-2203 Start Date*: 2019-03-15
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: A 3-Part, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate Safety and Efficacy of Avapritinib (BLU-285), a Selective KIT Mutation-Targeted Tyrosine Kinase Inhibitor, in Indole...
    Medical condition: Indolent Systemic Mastocytosis (ISM)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10042949 Systemic mastocytosis PT
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10056452 Indolent systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) DK (Trial now transitioned) IT (Trial now transitioned) SE (Trial now transitioned) FR (Trial now transitioned) NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005751-21 Sponsor Protocol Number: BLU-285-1408 Start Date*: 2021-04-16
    Sponsor Name:Blueprint Medicines
    Full Title: Open-Label Extension Study to Evaluate the Safety of Long-Term Treatment with Avapritinib for Patients Previously Involved in an Avapritinib Study
    Medical condition: Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10051066 Gastrointestinal stromal tumour PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065252 Solid tumor LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029104 Neoplasms benign, malignant and unspecified (incl cysts and polyps) SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004836-13 Sponsor Protocol Number: BLU-285-2202 Start Date*: 2018-12-29
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Ma...
    Medical condition: Advanced Systemic Mastocytosis (AdvSM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10056453 Aggressive systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA) NO (Completed) DE (Completed) ES (Ongoing) PL (Completed) FR (Completed) AT (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003497-14 Sponsor Protocol Number: BLU-285-1303 Start Date*: 2018-04-23
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients with Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)
    Medical condition: Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)
    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) 10051066 Gastrointestinal stromal tumour PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) SE (Completed) HU (Completed) DE (Completed) NL (Completed) AT (Completed) ES (Completed) BE (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-001535-87 Sponsor Protocol Number: BLU-263-2101 Start Date*: 2023-02-03
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: A Phase 1/2, open-label, 2-arm study evaluating BLU-263 as monotherapy and in combination with azacitidine, in patients with KIT altered hematologic malignancies
    Medical condition: Advanced Systemic Mastocytosis (AdvSM)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10042949 Systemic mastocytosis PT
    26.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10056453 Aggressive systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing)
    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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