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Clinical trials for Advanced Therapy Medicinal Product

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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    109 result(s) found for: Advanced Therapy Medicinal Product. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2018-001596-20 Sponsor Protocol Number: HelPIT-730-163-2018 Start Date*: 2018-12-21
    Sponsor Name:Helixor Heilmittel GmbH
    Full Title: Influence of a Helixor® P infusion therapy on the Cancer-related Fatigue (CrF) of female patients with advanced breast cancer or female or male patients with NSCLC during oncological standard thera...
    Medical condition: advanced breast cancer in female patients or advanced non-small cell lung cancer (NSCLC) in female or male patients during oncological standard therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000106-19 Sponsor Protocol Number: GO29689 Start Date*: 2015-12-10
    Sponsor Name:Genentech, Inc
    Full Title: A PHASE II, OPEN-LABEL, RANDOMIZED STUDY OF GDC-0810 VERSUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ADVANCED OR METASTATIC ER+/HER2- BREAST CANCER RESISTANT TO AROMATASE INHIBITOR THERAPY
    Medical condition: Advanced or Metastatic ER+/HER2- Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002488-91 Sponsor Protocol Number: MO39874 Start Date*: 2019-11-04
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN OPEN-LABEL, PHASE IIIB, SINGLE ARM, MULTICENTER STUDY OF ATEZOLIZUMAB (TECENTRIQ) PLUS NAB-PACLITAXEL IN THE TREATMENT OF UNRESECTABLE LOCALLY ADVANCED OR METASTATIC PD-L1-POSITIVE TRIPLE-NEGATI...
    Medical condition: Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075566 Triple negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) SI (Completed) FR (Completed) HU (Completed) SK (Prematurely Ended) IT (Completed) RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003185-25 Sponsor Protocol Number: GO29058 Start Date*: 2015-03-03
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY OF TASELISIB PLUS FULVESTRANT VERSUS PLACEBO PLUS FULVESTRANT IN POSTMENOPAUSAL WOMEN WITH ESTROGEN RECEPTOR POSITIVE AND HER2 NEGATI...
    Medical condition: WOMEN WITH ER-POSITIVE AND HER2-NEGATIVE, LOCALLY ADVANCED OR METASTATIC BREAST CANCER WHO HAS DIDEASE RECURRENCE OR PROGRESSION DURING OR AFTER AROMATASE INHIBITOR THERAPY
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) PT (Completed) ES (Completed) CZ (Completed) DE (Completed) AT (Completed) NL (Completed) PL (Completed) BG (Completed) FR (Completed) SE (Completed) GR (Completed) RO (Ongoing) FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-004486-86 Sponsor Protocol Number: SRA737-01 Start Date*: 2016-04-25
    Sponsor Name:Sierra Oncology, Inc.
    Full Title: A Phase 1/2 Trial of SRA737 (a Chk1 Inhibitor) Administered Orally in Subjects with Advanced Cancer
    Medical condition: Patients with histologically or cytologically proven advanced solid tumours, refractory to conventional treatment, or for which no conventional therapy is considered appropriate by the Investigator.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10007050 Cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-003582-18 Sponsor Protocol Number: 20190009 Start Date*: 2020-05-18
    Sponsor Name:Amgen, Inc.
    Full Title: A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC S...
    Medical condition: Previously treated locally advanced and unresectable or metastatic nonsmall cell lung cancer (NSCLC) with KRAS p.G12C mutation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Trial now transitioned) FR (Trial now transitioned) DK (Completed) PL (Trial now transitioned) FI (Completed) BE (Completed) PT (Completed) DE (Trial now transitioned) NL (Trial now transitioned) ES (Ongoing) HU (Completed) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002165-19 Sponsor Protocol Number: 20177308 Start Date*: 2019-05-10
    Sponsor Name:Medical University Vienna
    Full Title: Neo-BCC trial: Neoadjuvant treatment of difficult to resect, locally advanced basal cell carcinoma (BCC) with Talimogene laherparepvec (T-VEC)
    Medical condition: Basal cell carcinoma (BCC) is the most common malignant neoplasm in fair skinned humans (Rubin et al., 2005). Over the last decades its incidence has increased (Chinem and Miot, 2011). Especially w...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002654-21 Sponsor Protocol Number: S187.4.001 Start Date*: 2005-08-08
    Sponsor Name:Solvay Pharmaceuticals GmbH
    Full Title: A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia.
    Medical condition: Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfa...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2014-004852-77 Sponsor Protocol Number: GO29642 Start Date*: 2015-05-27
    Sponsor Name:Genentech, Inc
    Full Title: AN OPEN-LABEL, PHASE I/IIA STUDY OF GDC-0810 IN POSTMENOPAUSAL WOMEN WITH LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR POSITIVE BREAST CANCER
    Medical condition: Patients with locally advanced or metastatic estrogen receptor (ER) positive breast cancer
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10070575 Estrogen receptor positive breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2022-002189-34 Sponsor Protocol Number: HLX11-BC301 Start Date*: 2022-10-26
    Sponsor Name:Shanghai Henlius Biotech, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Pertuzumab Biosimilar HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy o...
    Medical condition: HER2-Positive and HR-Negative Early-stage or Locally advanced Breast Cancer
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER2 positive breast cancer PT
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10083232 HER2 negative breast cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) BG (Prematurely Ended) HU (Prematurely Ended) PL (Prematurely Ended) CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003645-25 Sponsor Protocol Number: 20110261 Start Date*: 2016-03-21
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 1, Multi-center, Open-label, Dose De-escalation Study to Evaluate the Safety and Efficacy of Talimogene Laherparepvec in Pediatric Subjects with Advanced Non Central Nervous SystemTumors Th...
    Medical condition: Non-Central Nervous System (CNS) Tumors
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Completed) SE (Prematurely Ended) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002732-75 Sponsor Protocol Number: MSC-ACLrep Start Date*: 2021-02-01
    Sponsor Name:Alexander IV sp. Partnership Ortopedika Surgery Specialistic Center
    Full Title: The use of mesenchymal stem cells from the bone marrow stroma for reconstruction of the anterior cruciate ligament
    Medical condition: Rupture of the anterior cruciate ligament in the knee
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10049548 Knee operation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004153-24 Sponsor Protocol Number: CRAD001JIT36T Start Date*: 2014-05-25
    Sponsor Name:Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche
    Full Title: MAINtenance Afinitor (MAIN-A): A randomized trial comparing maintenance aromatase inhibitors (AIs) + everolimus (Afinitor) vs. AIs in patients withHR+ metastatic breast cancer with disease control ...
    Medical condition: HR+ / HER2 negative metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005552-15 Sponsor Protocol Number: 20120325 Start Date*: 2015-05-18
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 2, Multicenter, Open-label, Single-arm Trial to Evaluate the Correlation Between Objective Response Rate and Baseline Immunoprofile Intratumoral CD8+ Cell Density in Subjects With Unresecte...
    Medical condition: Unresected stage IIIB to IVM1c melanoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) DE (Completed) BE (Completed) AT (Completed) HU (Completed) PL (Completed) GR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-004165-58 Sponsor Protocol Number: GO39590 Start Date*: 2017-02-21
    Sponsor Name:Genentech, Inc
    Full Title: A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY OF MOXR0916 IN COMBINATION WITH ATEZOLIZUMAB VERSUS ATEZOLIZUMAB ALONE IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR ME...
    Medical condition: Advanced or Metastatic Urothelial Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) PT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-001790-25 Sponsor Protocol Number: FP01C-13-001 Start Date*: 2014-09-01
    Sponsor Name:Foresee Pharmaceuticals Co., Ltd.
    Full Title: An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects with Advanced Prostate Carcinoma
    Medical condition: Advanced Prostate Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10036921 Prostate carcinoma LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Completed) DE (Completed) CZ (Completed) SK (Completed) LT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002430-23 Sponsor Protocol Number: TigetT10_MPS1H Start Date*: 2018-03-14
    Sponsor Name:OSPEDALE SAN RAFFAELE
    Full Title: A phase I/II study evaluating safety and efficacy of autologous hematopoietic stem and progenitor cells genetically modified with IDUA lentiviral vector encoding for the human α-L-iduronidase gene ...
    Medical condition: Mucopolysaccharidosis type I Hurler
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10056886 Mucopolysaccharidosis I PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001731-20 Sponsor Protocol Number: ML29741 Start Date*: 2016-03-09
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A SINGLE ARM, OPEN LABEL, PHASE II, MULTICENTER STUDY TO ASSESS THE DETECTION OF THE BRAF V600 MUTATION ON cfDNA FROM PLASMA IN PATIENTS WITH ADVANCED MELANOMA
    Medical condition: Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10053571 Melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-023978-39 Sponsor Protocol Number: 20080261 Start Date*: 2011-05-23
    Sponsor Name:Amgen Inc
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Trial of AMG 479 or Placebo in Combination with Gemcitabine as First-line Therapy for Locally Advanced Unresectable Adenocarcin...
    Medical condition: Locally advanced adenocarcinoma of the pancreas
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033606 Pancreatic cancer non-resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) GB (Prematurely Ended) DE (Prematurely Ended) PT (Prematurely Ended) BE (Prematurely Ended) AT (Prematurely Ended) CZ (Completed) PL (Prematurely Ended) SE (Prematurely Ended) HU (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004189-27 Sponsor Protocol Number: WO30085 Start Date*: 2016-10-21
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II STUDY OF THE EFFICACY AND SAFETY OF TRASTUZUMAB EMTANSINE IN COMBINATION WITH ATEZOLIZUMAB OR ATEZOLIZUMAB-PLACEBO IN PATIENTS W...
    Medical condition: Unresectable locally advanced or metastatic breast cancer (MBC).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10072740 Locally advanced breast cancer LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Completed) GB (Completed) IT (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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