Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Copanlisib

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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    12 result(s) found for: Copanlisib. Displaying page 1 of 1.
    EudraCT Number: 2015-001088-38 Sponsor Protocol Number: BAY80-6946/17833 Start Date*: 2015-12-09
    Sponsor Name:Bayer AG
    Full Title: A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in p...
    Medical condition: Patients with relapsed indolent non-Hodgkin's lymphoma
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) DE (Prematurely Ended) BE (Completed) CZ (Completed) DK (Prematurely Ended) ES (Prematurely Ended) GB (Completed) FR (Completed) PL (Prematurely Ended) IE (Prematurely Ended) AT (Prematurely Ended) PT (Prematurely Ended) HU (Completed) SK (Prematurely Ended) GR (Completed) BG (Prematurely Ended) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003893-29 Sponsor Protocol Number: BAY80-6946/17067 Start Date*: 2015-06-25
    Sponsor Name:Bayer AG
    Full Title: A Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non-Hodgkin’...
    Medical condition: Patients with relapsed indolent B-cell non-Hodgkin's lymphoma
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) PT (Completed) DE (Prematurely Ended) ES (Prematurely Ended) BE (Completed) LT (Completed) HU (Prematurely Ended) AT (Prematurely Ended) DK (Prematurely Ended) FR (Prematurely Ended) BG (Prematurely Ended) LU (Completed) GR (Completed) SK (Prematurely Ended) IT (Prematurely Ended) RO (Completed)
    Trial results: View results
    EudraCT Number: 2012-002602-52 Sponsor Protocol Number: BAY80-6946/16349 Start Date*: 2012-10-19
    Sponsor Name:Bayer AG
    Full Title: Open-label, uncontrolled Phase II trial of intravenous PI3K inhibitor BAY 80-6946 in patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas
    Medical condition: Patients with relapsed, indolent or aggressive Non-Hodgkin’s lymphomas or patients with follicular lymphoma relapsed after or refractory to standard therapy.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029600 Non-Hodgkin's lymphoma recurrent PT
    20.0 100000004851 10029621 Non-Hodgkin's lymphomas unspecified histology indolent HLT
    20.0 100000004851 10029608 Non-Hodgkin's lymphomas unspecified histology aggressive HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FI (Completed) DE (Completed) BE (Completed) ES (Completed) IT (Completed) SE (Completed) PL (Completed) AT (Completed) PT (Completed) HU (Completed) DK (Prematurely Ended) IE (Completed) GR (Completed) LU (Completed)
    Trial results: View results
    EudraCT Number: 2018-003560-31 Sponsor Protocol Number: UKM18_0021 Start Date*: 2020-01-29
    Sponsor Name:Universitätsklinikum Münster
    Full Title: A prospective multicenter phase 2 study of copanlisib in combination with rituximab and CHOP chemotherapy (COPA-R-CHOP) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL)
    Medical condition: diffuse large B-cell lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004848-36 Sponsor Protocol Number: BAY80-6946/17119 Start Date*: 2015-05-05
    Sponsor Name:Bayer AG
    Full Title: An open-label, single-arm Phase II study in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) to evaluate efficacy and safety of treatment with single agent copanlisib and ...
    Medical condition: patients with relapsed or refractory diffuse large B cell lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012821 Diffuse large B-cell lymphoma recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) GB (Completed) IT (Completed) ES (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-000925-19 Sponsor Protocol Number: BAY80-6946/17322 Start Date*: 2015-03-23
    Sponsor Name:Bayer Healthcare AG
    Full Title: A randomized, double-blind Phase III study of copanlisib versus placebo in patients with rituximab-refractory indolent non-Hodgkin’s lymphoma (iNHL) - CHRONOS-2
    Medical condition: Patients with rituximab-refractory indolent non-Hodgkin's lymphoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) IE (Completed) GR (Completed) PL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004340-19 Sponsor Protocol Number: UC-0130/1507 Start Date*: 2016-03-01
    Sponsor Name:UNICANCER
    Full Title: Phase Ib/II trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring...
    Medical condition: Recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) harboring a PI3KCA mutation/amplification and/or a PTEN loss
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060121 Squamous cell carcinoma of head and neck PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-004038-13 Sponsor Protocol Number: ALTERNATIVE-C Start Date*: 2020-06-25
    Sponsor Name:Klinikum der Universität München
    Full Title: A Prospective Multicenter Phase 2 Study of the Chemotherapy-Free Combination of the Intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination with Obinutuzumab in Patient...
    Medical condition: Follicular Lymphoma with high tumor burden (grade 1- 3a, Ann Arbour stage II - IV, previously untreated)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016908 Follicle centre lymphoma, follicular grade I, II, III stage II PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016909 Follicle centre lymphoma, follicular grade I, II, III stage III PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016910 Follicle centre lymphoma, follicular grade I, II, III stage IV PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003150-16 Sponsor Protocol Number: COUP-1 Start Date*: 2018-11-21
    Sponsor Name:University Hospital Ulm
    Full Title: Copanlisib and Rituximab in Marginal Zone Lymphoma Patients
    Medical condition: Marginal Zone Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062113 Splenic marginal zone lymphoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10076596 Marginal zone lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000383-15 Sponsor Protocol Number: BAY80-6946/19176 Start Date*: 2023-06-05
    Sponsor Name:Bayer AG
    Full Title: A non-randomized, open-label, multi-center, Phase I/II study of PI3K inhibitor copanlisib in pediatric patients with relapsed/refractory solid tumors or lymphoma
    Medical condition: Relapsed or refractory solid tumors or lymphoma in children Neuroblastoma Osteosarcoma Rhabdomyosarcoma Ewing sarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025310 Lymphoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029260 Neuroblastoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10031291 Osteosarcoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10039022 Rhabdomyosarcoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015560 Ewing's sarcoma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004898-63 Sponsor Protocol Number: FIL_Copa-RB Start Date*: 2020-08-18
    Sponsor Name:FONDAZIONE ITALIANA LINFOMI ONLUS
    Full Title: Copanlisib in combination with Rituximab-Bendamustine in patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma: a multicentric Phase II trial
    Medical condition: Patients with Relapsed-Refractory Diffuse Large B-cell Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10012818 Diffuse large B-cell lymphoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003687-36 Sponsor Protocol Number: ICORG1502 Start Date*: 2015-12-04
    Sponsor Name:Cancer Trials Ireland CLG
    Full Title: Phase IB/II clinical trial of copanlisib in combination with trastuzumab in pretreated recurrent or metastatic HER2-positive breast cancer
    Medical condition: HER2 positive metastatic or recurrent breast cancer, following disease progression during, or after, treatment with at least one treatment regimen in the metastatic or recurrent setting.
    Disease: Version SOC Term Classification Code Term Level
    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) 10006198 Breast cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue Jun 10 06:11:51 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA