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Clinical trials for Accelerated approval

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    9 result(s) found for: Accelerated approval. Displaying page 1 of 1.
    EudraCT Number: 2010-019866-96 Sponsor Protocol Number: IPM3001 Start Date*: 2010-12-07
    Sponsor Name:ZIOPHARM Oncology Inc
    Full Title: A Phase III multicenter, international, randomized, double-blind, placebo-controlled study of doxorubicin plus palifosfamide-tris vs. doxorubicin plus placebo in patients with front-line metastatic...
    Medical condition: metastatic soft tissue sarcomas, previously untreated
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) GB (Prematurely Ended) ES (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-000691-15 Sponsor Protocol Number: B1871040 Start Date*: 2013-07-08
    Sponsor Name:Pfizer Inc, 235 East 42nd Street, New York, NY 10017
    Full Title: AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008
    Medical condition: Chronic Myeloid Leukemia (CML)
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004864 10009012 Chronic myelogenous leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) HU (Completed) LT (Prematurely Ended) LV (Completed) NL (Completed) FI (Completed) ES (Completed) GB (Completed) FR (Completed) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004281-28 Sponsor Protocol Number: POLARIS2015-003 Start Date*: 2017-01-23
    Sponsor Name:Polaris Pharmaceuticals, Inc.
    Full Title: Randomized, Double-Blind, Phase 2/3 Study in Subjects with Malignant Pleural Mesothelioma to Assess ADI-PEG 20 with Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)
    Medical condition: Advanced malignant pleural mesothelioma (MPM)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10035605 Pleural mesothelioma malignant advanced LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-006916-39 Sponsor Protocol Number: IVH06 Start Date*: 2009-07-23
    Sponsor Name:Johns Hopkins University
    Full Title: Clot lysis: evaluating accelerated resolution of intraventricular hemorrhage Phase III
    Medical condition: Intraventricular haemorrhage
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10022840 Intraventricular haemorrhage PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (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)
    EudraCT Number: 2019-001925-28 Sponsor Protocol Number: FGCL-3019-087 Start Date*: 2020-03-11
    Sponsor Name:FibroGen, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in combination with either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients with Locally Advanc...
    Medical condition: Locally Advanced, Unresectable Pancreatic Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10033606 Pancreatic cancer non-resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) ES (Restarted) DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000893-32 Sponsor Protocol Number: 008171BLT Start Date*: 2014-02-17
    Sponsor Name:Queen Mary University of London
    Full Title: Squamous cell carcinoma prevention in organ transplant recipients using topical treatments: a feasibility study (SPOT)
    Medical condition: Actinic keratosis (and cutaneous squamous cell carcinoma)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10000614 Actinic keratosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-001168-35 Sponsor Protocol Number: A4021018 Start Date*: 2008-07-09
    Sponsor Name:PFIZER, S.A.
    Full Title: ENSAYO ALEATORIZADO, ABIERTO, EN FASE 3 DE ERLOTINIB SOLO O EN COMBINACION CON CP-751,871 EN PACIENTES CON CANCER DE PULMON NO MICROCITICO AVANZADO DE HISTOLOGIA NO ADENOCARCINOMATOSA.
    Medical condition: CPNM avanzado de histología no adenocarcinomatosa.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) SI (Completed) IE (Completed) GB (Completed) BE (Completed) IT (Prematurely Ended) LV (Completed) FR (Completed) BG (Completed) HU (Completed) CZ (Prematurely Ended) GR (Completed)
    Trial results: View results
    EudraCT Number: 2012-004391-19 Sponsor Protocol Number: 3475-010 Start Date*: 2013-04-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., (Merck)
    Full Title: A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) versus Docetaxel in Previously Treated Subjects with Non-Small Cell Lung Cancer
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10066490 Progression of non-small cell lung cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) LT (Completed) HU (Completed) BE (Completed) ES (Completed) DK (Completed) DE (Completed) IT (Completed) NL (Completed) FR (Completed) PT (Completed) GR (Completed)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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