Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Giotrif | — | 2013-09-25 | europa.eu ↗ |
Trials 189 · started per year
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05432518 | Jun 2023 → Jul 2027 expected | adult glioblastoma | AHS Cancer Control Alberta | Recruiting | No outcome recorded |
| Phase 151 trials | ||||||
| Phase 1 | NCT06897735 | Nov 2025 → May 2026 | lung cancer, melanoma, oral cavity cancer | Petrov, Andrey | Terminated | No outcome recorded |
| Phase 1 | NCT06741982 | Dec 2024 → Dec 2026 expected | head and neck squamous cell carcinoma | West China Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06494189 | Jul 2024 → Apr 2025 | head and neck cancer | West China Hospital | Completed | No outcome recorded |
| Phase 1 | NCT06302621 | Apr 2024 → Dec 2027 expected | cholangiocarcinoma, metastatic neoplasm, refractory malignant neoplasm | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT05927844 | Jun 2023 → Jun 2025 | esophageal squamous cell carcinoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 1 | NCT05164848 | Dec 2021 → Oct 2023 | esophageal squamous cell carcinoma | Peking University | Unknown | No outcome recorded |
| Phase 1 | NCT03878524 | Apr → Dec 2020 | acute myeloid leukemia, atypical chronic myeloid leukemia, BCR-ABL1 negative, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, castration-resistant prostate carcinoma +14 | OHSU Knight Cancer Institute | Terminated | No outcome recorded |
| Phase 1 | NCT04185883 | Dec 2019 → Dec 2026 expected | cancer | Amgen | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03827070 | Mar 2019 → Feb 2023 | non-small cell lung carcinoma | Center Trials & Treatment Europe | Unknown | No outcome recorded |
| Phase 1 | NCT03711422 | Nov 2018 → Dec 2019 | central nervous system neoplasm, neoplastic meningitis, non-small cell lung carcinoma | National Cancer Centre, Singapore | Terminated | No outcome recorded |
| Phase 1 | NCT03652233 | Nov 2018 → Nov 2021 | head and neck squamous cell carcinoma | Vanderbilt-Ingram Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT03054038 | Jul 2017 → Mar 2022 | non-small cell lung carcinoma | Vanderbilt-Ingram Cancer Center | Terminated | No outcome recorded |
| Phase 1 | NCT02423525 | Dec 2016 → Aug 2020 | brain cancer | Santosh Kesari | Completed | No outcome recorded |
| Phase 1 | NCT02975141 | Sep 2016 → Dec 2018 | pancreatic ductal adenocarcinoma | PD Dr. med. Volker Heinemann | Unknown | No outcome recorded |
| Phase 1 | NCT02364609 | Sep 2015 → Apr 2018 | non-small cell lung carcinoma | Jonathan Riess | Completed | No outcome recorded |
| Phase 1 | NCT02145637 | May 2015 → Nov 2017 | non-small cell lung carcinoma | Yonsei University | Completed | No outcome recorded |
| Phase 1 | NCT02191891 | Oct 2014 → Apr 2018 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02216617 | Aug 2014 → Jul 2015 | head and neck squamous cell carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Completed | No outcome recorded |
| Phase 1 | NCT02096718 | May → Dec 2014 | impaired renal function disease | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01999985 | Dec 2013 → Mar 2017 | non-small cell lung carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT02020577 | Dec 2013 → Jan 2015 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01836341 | Apr 2013 → Apr 2015 | non-small cell lung carcinoma | Memorial Sloan Kettering Cancer Center | Withdrawn | No outcome recorded |
| Phase 1 | NCT01783587 | Feb 2013 → Nov 2017 | head and neck squamous cell carcinoma | Dana-Farber Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT01721525 | Nov 2012 → Oct 2017 | head and neck cancer, squamous cell carcinoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01679405 | Aug 2012 → Apr 2016 | metastatic neoplasm | Johannes Gutenberg University Mainz | Terminated | No outcome recorded |
| Phase 1 | NCT01649271 | Jul 2012 → Jun 2016 | breast cancer, gastric neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01647711 | Jul 2012 → Sep 2015 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01426958 | Aug → Dec 2011 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01396265 | Jul → Aug 2011 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01298063 | Feb 2011 → Jan 2012 | liver disorder | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01206816 | Oct 2010 → Nov 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01214616 | Oct 2010 → May 2013 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01169675 | Jul 2010 → Nov 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01090011 | Mar 2010 → Jan 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00998296 | Oct 2009 → Dec 2012 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00993499 | Oct 2009 → Sep 2014 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00977431 | Sep 2009 → Sep 2017 | glioblastoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171754 | Sep → Dec 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00950742 | Aug 2009 → Oct 2013 | breast cancer | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171767 | Aug → Oct 2009 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00906698 | Jun 2009 → Jan 2013 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00716417 | Jul 2008 → Jul 2010 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00809133 | May 2007 → Feb 2015 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00730821 | Jan 2007 → Aug 2009 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171676 | May 2005 → Mar 2008 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171741 | Apr 2005 → Dec 2007 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171650 | Dec 2004 → May 2006 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171702 | Nov 2004 → Mar 2007 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171728 | Nov 2004 → Sep 2006 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171663 | Mar 2004 → Feb 2006 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02171637 | Nov 2003 → Feb 2006 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/213 trials | ||||||
| Phase 1/2 | NCT06753747 | Sep 2025 → Sep 2027 expected | esophageal cancer | West China Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07010120 | Jun 2025 → May 2027 expected | head and neck squamous cell carcinoma | West China Hospital | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06648096 | Nov 2024 → Dec 2028 expected | Fanconi anemia, head and neck squamous cell carcinoma | Sant Pau Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06085755 | Sep 2024 → Dec 2025 overdue | gastric neoplasm | Jeeyun Lee | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06071013 | Feb 2024 → Aug 2026 overdue | non-small cell lung carcinoma | China Medical University Hospital | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03481842 | Oct 2021 | endometriosis of intestine, ovarian endometriosis | BioGene Pharmaceutical Ltd. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03785249 | Jan 2019 → Dec 2026 expected | metastatic malignant neoplasm | Mirati Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03623750 | Jul 2018 → Mar 2020 | non-small cell lung carcinoma | Instituto Oncológico Dr Rosell | Completed | No outcome recorded |
| Phase 1/2 | NCT02450656 | Jun 2015 → May 2019 | colorectal neoplasm, non-small cell lung carcinoma, pancreatic neoplasm | The Netherlands Cancer Institute | Unknown | No outcome recorded |
| Phase 1/2 | NCT02372006 | Apr 2015 → Aug 2020 | neuroepithelial neoplasm, rhabdomyosarcoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1/2 | NCT02768337 | Mar 2015 → Aug 2020 | brain cancer, breast cancer, lung cancer | Cambridge University Hospitals NHS Foundation Trust | Terminated | No outcome recorded |
| Phase 1/2 | NCT01861223 | May 2013 → May 2015 | non-small cell lung carcinoma | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 1/2 | NCT01732640 | Dec 2012 → Nov 2016 | head and neck squamous cell carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| Phase 295 trials | ||||||
| Phase 2 | NCT07040956 | Jun 2025 → Jun 2026 | head and neck squamous cell carcinoma | West China Hospital | Completed | No outcome recorded |
| Phase 2 | NCT06709859 | May 2025 → May 2026 overdue | non-small cell lung carcinoma | Shandong Public Health Clinical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06804850 | Jan 2025 → Jun 2026 | head and neck cancer | West China Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT06062823 | Mar 2024 → Oct 2026 expected | non-small cell lung carcinoma | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 2 | NCT05865132 | Apr 2023 → Apr 2025 | esophageal squamous cell carcinoma | Aiping Zhou | Unknown | No outcome recorded |
| Phase 2 | NCT05818982 | Feb 2023 → Feb 2025 | esophageal squamous cell carcinoma | Peking University | Unknown | No outcome recorded |
| Phase 2 | NCT05519917 | Oct 2022 → Jun 2025 | clivus chordoma | Huashan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT05517330 | Sep 2022 → Dec 2023 | head and neck squamous cell carcinoma | West China Hospital | Completed | No outcome recorded |
| Phase 2 | NCT05516589 | Sep 2022 → Oct 2023 | head and neck squamous cell carcinoma | West China Hospital | Completed | No outcome recorded |
| Phase 2 | NCT04410653 | Jul 2022 → Oct 2023 | — | German Cancer Research Center | Completed | No outcome recorded |
| Phase 2 | NCT05298176 | Jan 2022 → Apr 2024 | non-small cell lung carcinoma | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| Phase 2 | NCT05070403 | Oct 2021 → Feb 2027 expected | squamous cell carcinoma | H. Lee Moffitt Cancer Center and Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05215548 | Sep 2021 → Oct 2026 expected | non-small cell lung carcinoma | National Taiwan University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04839471 | Aug 2021 → Jul 2023 | esophageal squamous cell carcinoma | National Health Research Institutes, Taiwan | Completed | No outcome recorded |
| Phase 2 | NCT04497584 | Aug 2021 → Sep 2026 expected | non-small cell squamous lung carcinoma | University of Texas Southwestern Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04880811 | Jul 2021 → Oct 2022 | esophageal squamous cell carcinoma | Peking University | Unknown | No outcome recorded |
| Phase 2 | NCT05267288 | Feb 2021 → Dec 2024 | — | Qingdao Central Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT04533321 | Sep 2020 → Sep 2023 | squamous cell carcinoma | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 2 | NCT04201756 | Jul 2020 → Feb 2022 | lung adenocarcinoma | Shanghai Pulmonary Hospital, Shanghai, China | Completed | No outcome recorded |
| Phase 2 | NCT04470076 | Jul 2020 → Dec 2021 | non-small cell lung carcinoma | Fifth Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 2 | NCT04183712 | Jun 2020 → Jun 2025 overdue | gallbladder carcinoma | Shanghai Jiao Tong University School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT04158947 | May 2020 → Dec 2023 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | xuexin he | Unknown | No outcome recorded |
| Phase 2 | NCT03940976 | Apr 2019 → Jan 2020 | esophageal squamous cell carcinoma | Peking University | Unknown | No outcome recorded |
| Phase 2 | NCT03695510 | Jan 2019 → Apr 2022 | head and neck neoplasm | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03727724 | Dec 2018 → Sep 2022 | non-small cell lung carcinoma | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT03574402 | Jul 2018 → Dec 2022 | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Unknown | No outcome recorded |
| Phase 2 | NCT03083678 | Jun 2018 → Jan 2025 | chordoma | Leiden University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT03486509 | Apr 2018 → Mar 2020 | squamous cell carcinoma | Fujian Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06385483 | Feb 2018 → Dec 2022 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03088059 | Nov 2017 → Jun 2025 | head and neck squamous cell carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | No outcome recorded |
| Phase 2 | NCT03157089 | Nov 2017 → Jan 2020 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02122172 | Sep 2017 → Apr 2024 | ureter cancer, urethra cancer, urinary bladder carcinoma | University of Chicago | Terminated | No outcome recorded |
| Phase 2 | NCT02876081 | Sep 2017 | small cell lung carcinoma | Fondation Hôpital Saint-Joseph | Withdrawn | No outcome recorded |
| Phase 2 | NCT03810872 | Jun 2017 → Dec 2020 | — | University Hospital Brussels | Unknown | No outcome recorded |
| Phase 2 | NCT02979977 | Mar 2017 → Jan 2025 | head and neck squamous cell carcinoma | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT03239015 | Jan 2017 → Jun 2023 | refractory malignant neoplasm | Baodong Qin | Unknown | No outcome recorded |
| Phase 2 | NCT02183883 | Dec 2016 → Mar 2023 | non-small cell lung carcinoma | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT02795156 | Sep 2016 → Aug 2022 | digestive system carcinoma, non-small cell lung carcinoma, upper aerodigestive tract neoplasm, urothelial carcinoma | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02925234 | Aug 2016 → Sep 2027 expected | cancer | The Netherlands Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT02501603 | Jul 2016 → Dec 2021 | gastric cancer, gastroesophageal cancer | Yonsei University | Completed | No outcome recorded |
| Phase 2 | NCT02780687 | Jun 2016 → Sep 2018 | urinary system neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02629523 | Jun 2016 → Dec 2018 | lung cancer | Chonnam National University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02716311 | May 2016 → Feb 2019 | non-small cell lung carcinoma | French Cooperative Thoracic Intergroup | Completed | No outcome recorded |
| Phase 2 | NCT02597946 | Mar 2016 → Jul 2018 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT02470065 | Jan 2016 → Sep 2018 | non-small cell lung carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Suspended | No outcome recorded |
| Phase 2 | NCT02595840 | Nov 2015 → Nov 2017 | lung cancer | University of Duisburg-Essen | Terminated | No outcome recorded |
| Phase 2 | NCT02488694 | Nov 2015 → Dec 2017 | lung cancer | AIO-Studien-gGmbH | Terminated | No outcome recorded |
| Phase 2 | NCT02369484 | Sep 2015 → Sep 2017 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Completed | No outcome recorded |
| Phase 2 | NCT02465060 | Aug 2015 → Dec 2026 expected | breast carcinoma, carcinoma of esophagus, cervical carcinoma, colon carcinoma +17 | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04439136 | Aug 2015 → Jan 2021 overdue | adult lymphoma, plasma cell myeloma, refractory malignant neoplasm | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02511847 | Aug 2015 → Jul 2017 | triple-negative breast carcinoma | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02506517 | Aug 2015 → May 2023 | cancer | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT02271906 | Jul 2015 → Aug 2017 | lung cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT02491099 | Jun 2015 → Dec 2026 expected | endometrial serous adenocarcinoma | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT02353936 | Jan 2015 → Jan 2020 | esophageal squamous cell carcinoma | Yonsei University | Unknown | No outcome recorded |
| Phase 2 | NCT02115048 | Jul 2014 → Nov 2018 | breast neoplasm | Translational Research in Oncology | Terminated | No outcome recorded |
| Phase 2 | NCT01824823 | Jun 2014 → Dec 2015 | head and neck squamous cell carcinoma | ECOG-ACRIN Cancer Research Group | Terminated | No outcome recorded |
| Phase 2 | NCT02274012 | May 2014 → Aug 2015 | esophageal cancer, gastroesophageal adenocarcinoma, gastroesophageal cancer | Columbia University | Withdrawn | No outcome recorded |
| Phase 2 | NCT02142036 | May 2014 → Aug 2018 | metastatic malignant neoplasm | Oslo University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01728818 | Apr 2013 → Jan 2017 | — | PD Dr. med. Volker Heinemann | Unknown | No outcome recorded |
| Phase 2 | NCT01743365 | Feb 2013 → Jun 2019 | gastric cancer, gastroesophageal cancer | Hellenic Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT01932229 | Feb 2013 → Jan 2015 | non-small cell lung carcinoma | Sheba Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02625168 | Jan 2013 → Sep 2014 | lung cancer | The University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT01415011 | Dec 2012 → Aug 2015 | non-small cell lung carcinoma | University College, London | Completed | No outcome recorded |
| Phase 2 | NCT01919879 | Oct 2012 → Nov 2015 | colorectal cancer | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT01538381 | Jul 2012 → Aug 2015 | head and neck squamous cell carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 2 | NCT01531764 | Jul 2012 → Sep 2013 | breast carcinoma | University of Magdeburg | Terminated | No outcome recorded |
| Phase 2 | NCT01594177 | May 2012 → Mar 2014 | HER2 positive breast carcinoma | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01553942 | Apr 2012 → Dec 2024 overdue | lung cancer | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01522768 | Mar 2012 → Feb 2023 | esophageal cancer, gastric cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01415674 | Jan 2012 → Dec 2021 | head and neck squamous cell carcinoma | UNICANCER | Completed | No outcome recorded |
| Phase 2 | NCT01480141 | Jan → Aug 2012 | lung cancer | Medical University of South Carolina | Withdrawn | No outcome recorded |
| Phase 2 | NCT01542437 | Jan 2012 → Jun 2014 | non-small cell lung carcinoma | National Cancer Institute of Mexico | Completed | No outcome recorded |
| Phase 2 | NCT01466660 | Dec 2011 → Apr 2016 | lung neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01441596 | Oct 2011 → Feb 2014 | breast cancer, metastatic malignant neoplasm in the brain | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01325428 | Aug 2011 → Nov 2014 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01271725 | May 2011 → Mar 2017 | breast cancer | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01320280 | May 2011 → Nov 2012 | refractory malignant neoplasm | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded |
| Phase 2 | NCT01156545 | Oct 2010 → Dec 2016 | non-small cell lung carcinoma | National Cancer Center, Korea | Completed | No outcome recorded |
| Phase 2 | NCT01152437 | Jun 2010 → Mar 2012 | colorectal neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT01003899 | Oct 2009 → Nov 2011 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00875433 | Mar 2009 → Apr 2011 | neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00826267 | Jan 2009 → Aug 2011 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00796549 | Dec 2008 → May 2012 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00748709 | Oct 2008 → Nov 2010 | neoplasm | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2 | NCT00727506 | Jul 2008 → May 2011 | glioma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00730925 | Jun 2008 → Jan 2012 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00711594 | Apr 2008 → Nov 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00514943 | Aug 2007 → Mar 2010 | head and neck neoplasm, squamous cell carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00525148 | Aug 2007 → Feb 2010 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00708214 | Jan 2007 → Feb 2010 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00425854 | Nov 2006 → May 2009 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00431067 | Sep 2006 → Aug 2009 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00801294 | Jul 2006 → Nov 2007 | colorectal neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00706628 | Mar 2006 → Dec 2008 | prostate neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07653451 | Jul 2026 → Dec 2027 expected | esophageal squamous cell carcinoma | Peking University Cancer Hospital & Institute | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT02438722 | May 2015 → Sep 2018 | non-small cell lung carcinoma | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 315 trials | ||||||
| Phase 3 | NCT02131155 | Jul 2014 → Aug 2016 | head and neck neoplasm | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT02044380 | Mar 2014 → Feb 2016 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01953913 | Sep 2013 → Jul 2018 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01853826 | Jul 2013 → Mar 2024 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01856478 | Jun 2013 → Aug 2018 | head and neck neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01814553 | Apr 2013 → Jul 2015 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01523587 | Mar 2012 → Oct 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01345682 | Jan 2012 → Mar 2014 | head and neck neoplasm, squamous cell carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01345669 | Oct 2011 → Sep 2016 | head and neck neoplasm | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 3 | NCT01427478 | Sep 2011 → Nov 2020 | head and neck squamous cell carcinoma | Centre Leon Berard | Completed | No outcome recorded |
| Phase 3 | NCT01125566 | Jun 2010 → Jun 2013 | breast cancer | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01121393 | Apr 2010 → Nov 2017 | adenocarcinoma, non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT01085136 | Feb 2010 → Oct 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00949650 | Aug 2009 → Feb 2012 | adenocarcinoma, non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 3 | NCT00656136 | Apr 2008 → Oct 2013 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT04814056 | Jun 2021 → Sep 2023 | non-small cell lung carcinoma | Shanghai Chest Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04413201 | Sep 2020 → Dec 2026 expected | non-small cell lung carcinoma | Michael Hopp | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04132102 | Nov 2018 → Apr 2021 | squamous cell lung carcinoma | Shanghai Chest Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02695290 | Mar → Aug 2016 | non-small cell lung carcinoma | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 4 | NCT02514174 | Aug 2015 → Mar 2019 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 4 | NCT02208843 | Oct 2014 → May 2017 | non-small cell lung carcinoma | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT01074177 | Feb 2011 → Mar 2017 | RET fusion positive cancer, non-small cell lung carcinoma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase not stated4 trials | ||||||
| — | NCT01649284 | Jul 2012 → Mar 2014 | non-small cell lung carcinoma | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT01931306 | — | non-small cell lung carcinoma | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT01209650 | — | non-small cell lung carcinoma | Boehringer Ingelheim | Approved for marketing | No outcome recorded |
| — | NCT05107193 | — | cancer | Boehringer Ingelheim | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07271446 Background | Sep 2018 → Aug 2019 | non-small cell lung carcinoma | Precision Biotech Taiwan Corp. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02906163 Background | Oct 2016 → Dec 2019 | lung cancer | SciClone Pharmaceuticals | Unknown | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05588609 Background | Nov 2022 → Jul 2025 | castration-resistant prostate carcinoma | Partner Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT01746251 Comparator | Jan 2013 → Nov 2020 | non-small cell lung carcinoma | Massachusetts General Hospital | Unknown | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07185997 Comparator | Dec 2025 → Feb 2029 expected | non-small cell lung carcinoma | ArriVent BioPharma, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06486142 Comparator | Sep 2022 → Sep 2028 expected | non-small cell lung carcinoma | Region Skane | Recruiting | No outcome recorded |
| Phase 3 | NCT06759857 Comparator | Aug 2021 → Mar 2025 overdue | non-small cell lung carcinoma | Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | Enrolling by invitation | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04356118 Background | Jun 2020 → Jun 2023 | malignant leptomeningeal tumor | Hui Bu | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03071705 Background | Mar 2016 → Apr 2017 | lung adenocarcinoma | National Cancer Institute of Mexico | Unknown | No outcome recorded |
| — | NCT01776684 Background | Jun 2012 → May 2014 | lung cancer | Samsung Medical Center | Unknown | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 204 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Afatinib | “Afatinib-an oral irreversible ErbB family blocker-improves progression-free survival compared with pemetrexed and cisplatin for first-line treatment of patients with EGFR...” PMID 24439929 ↗ Jan 2014169“This is an investigational study. Afatinib is FDA approved and commercially available to be the first treatment for patients with a specific type of NSCLC that has spread. It...” NCT02271906 ↗ “Patients were randomly allocated to receive EGFR-TKIs (erlotinib hydrochloride, afatinib dimaleate, or gefitinib at standard dosage) plus metformin hydrochloride (500 mg twice...” PMID 31486833 ↗ Nov 2019 “evaluate the efficacy and safety of XH-30002 capsule in combination with afatinib maleate tablets in patients with locally advanced or metastatic esophageal squamous cell carcinoma” NCT05927844 ↗ “A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations” NCT01647711 ↗ “Study to Determine the Maximum Tolerated Dose of BIBW 2992 (Afatinib) When Combined With Cisplatin/Paclitaxel or Cisplatin/5-FU in Patients With Advanced Solid Tumours” NCT00716417 ↗ “A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers.” NCT00875433 ↗ “Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.” NCT00950742 ↗ “Patients will commence daily oral therapy with the EGFR TKI afatinib as soon as possible, preferably on the same day as low dose cyclophosphamide.” NCT03623750 ↗ “The MTD was determined as afatinib 30 mg in combination with daily TMZ and RT, and afatinib 40 mg in combination with RT alone.” PMID 34787778 ↗ Nov 2021 “PURPOSE: Afatinib, an irreversible ErbB family blocker, has demonstrated preclinical antitumor activity with chemotherapy.” PMID 30088048 ↗ Aug 2018 “LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment” NCT01125566 ↗ “6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab” NCT00826267 ↗ “Phase I study of continuous afatinib (BIBW 2992) in patients with advanced non-small cell lung cancer” PMID 22071596 ↗ Nov 2011 “BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation” NCT00949650 ↗ “A phase I study of volasertib combined with afatinib, in advanced solid tumors.” PMID 26349473 ↗ Sep 2015 “BIBW 2992 (Afatinib) in Combination With Pemetrexed in Advanced Solid Tumours” NCT01169675 ↗ “A Study of BIBW 2992 (Afatinib) in Patients With Metastatic Colorectal Cancer” NCT01152437 ↗ “osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet” NCT07185997 ↗ “Afatinib is a potent irreversible ErbB family blocker.” PMID 22325357 ↗ Feb 2012 “following drugs: Afatinib Arsenic trioxide Axitinib” NCT02551718 ↗ “BIBW 2992 (Afatinib) once daily until progression” NCT00431067 ↗ “BIBW 2992 (Afatinib) in Head & Neck Cancer” NCT00514943 ↗ “Erlotinib，Afatinib，Osimertinib” NCT04356118 ↗ “afatinib, gefitinib, erlotinib” NCT02906163 ↗ “BIBW 2992 (Afatinib)” NCT00727506 ↗ “BIBW 2992 (Afatinib)” NCT00748709 ↗ “BIBW 2992 (Afatinib)” NCT00993499 ↗ “Afatinib” NCT02142036 ↗ |
| Known as | Afatinib Dimaleate | “Patients were randomly allocated to receive EGFR-TKIs (erlotinib hydrochloride, afatinib dimaleate, or gefitinib at standard dosage) plus metformin hydrochloride (500 mg twice...” PMID 31486833 ↗ Nov 20191“Drug: Afatinib Dimaleate” NCT02364609 ↗ |
| Known as | BIBW 2992 | “A Phase Ib Open-label Clinical Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 Plus Cetuximab (Erbitux®) in Patients With Non-small cell Lung Cancer With...” NCT01090011 ↗68“Trial of Continuous Once Daily Oral Treatment Using BIBW 2992 (Afatinib) Plus Sirolimus (Rapamune®) in Patients With Non-small Cell Lung Cancer Harbouring an EGFR Mutation...” NCT00993499 ↗ “An Open Label Expanded Access Program of Afatinib (BIBW 2992) in Treatment-naive or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-Small Cell Lung...” NCT01931306 ↗ “LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the...” NCT01271725 ↗ “LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After...” NCT01345682 ↗ “So far, there is uncertainty, if afatinib (BIBW 2992), an irreversible HER family blocker can lead to an even more complete blockade of the HER2 pathway when given in...” NCT01594177 ↗ “LUX-Lung EAP US; An Open Label Expanded Access Program of Afatinib (BIBW 2992) for Patients With Locally Advanced or Metastatic Non-small cell Lung Cancer (NSCLC) Harboring...” NCT01649284 ↗ “LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy” NCT01523587 ↗ “LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy” NCT01345669 ↗ “An Open Label Phase I Dose Escalation Trial of Intravenous BI 6727 (Volasertib)in Combination With Oral BIBW 2992 (Afatinib) in Patients With Advanced Solid Tumours” NCT01206816 ↗ “A phase II trial to assess the impact of afatinib (BIBW 2992) on the heart (QTcF) and the effectiveness of afatinib (BIBW 2992) in treating certain cancers.” NCT00875433 ↗ “Open Label Trial to Explore Safety of Combining Afatinib (BIBW 2992) and Radiotherapy With or Without Temozolomide in Newly Diagnosed Glioblastoma Multiform” NCT00977431 ↗ “BIBW 2992 will be given in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy” NCT01085136 ↗ “Clinical activity of afatinib (BIBW 2992) in patients with lung adenocarcinoma with mutations in the kinase domain of HER2/neu.” PMID 22325357 ↗ Feb 2012 “Afatinib (BIBW 2992) is an ErbB-family blocker that irreversibly inhibits signaling from all relevant ErbB-family dimers.” NCT02511847 ↗ “LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment” NCT01125566 ↗ “Afatinib (BIBW2992) in HER2 (Human Epidermal Growth Factor Receptor 2)-Overexpressing Inflammatory Breast Cancer” NCT01325428 ↗ “Trial of Afatinib (BIBW 2992) in Suspected or Confirmed Mutant EGFR Lung Cancer Patients Unfit for Chemotherapy” NCT01415011 ↗ “Afatinib (BIBW 2992) is a novel irreversible EGFR1- and HER2 and HER4 inhibitor that is applied orally.” NCT01728818 ↗ “Phase I study of continuous afatinib (BIBW 2992) in patients with advanced non-small cell lung cancer” PMID 22071596 ↗ Nov 2011 “International Nonproprietary Name (INN): BIBW 2992 Pharmacological dosage form: Film-coated tablet” NCT02353936 ↗ “BIBW 2992 (Afatinib) is a drug which in advanced clinical testing in lung and breast cancer.” NCT01320280 ↗ “BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation” NCT00949650 ↗ “Afatinib (BIBW2992) is a small molecule, selective and irreversible erbB family blocker.” NCT02876081 ↗ “Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation” NCT01953913 ↗ “BIBW 2992 (Afatinib) and Vinorelbine in Japanese Patients With Advanced Solid Tumours” NCT01214616 ↗ “Trial of Afatinib (BIBW 2992) + Cetuximab in Advanced Solid Tumours” NCT02020577 ↗ “Trial Exploring Afatinib (BIBW 2992) + Paclitaxel” NCT00809133 ↗ “Afatinib (BIBW-2992) 40mg per os” NCT01743365 ↗ “afatinib (BIBW 2992) po QD” NCT01003899 ↗ “BIBW 2992 (Afatinib)” NCT01480141 ↗ “Afatinib (BIBW2992)” NCT02131155 ↗ “Drug: BiBW 2992” NCT00796549 ↗ |
| Known as | GILOTRIF | “This phase I/Ib trial will assess the dose, safety and side effects of the combination of the cancer drugs afatinib (GILOTRIF®) and nivolumab (OPDIVO®) and to assess the...” NCT03652233 ↗3“will be treated with orally administered daily dose of afatinib (Gilotrif®) in a fasting state (1 hour before or 2 hours after meals).” NCT04533321 ↗ “Afatinib (Gilotrif™) is currently used for metastatic non-small-cell lung cancer with EGFR mutations” PMID 34004576 ↗ May 2021 “Afatinib (GILOTRIF) is a highly potent, irreversible inhibitor of the EGFR and HER2.” NCT02274012 ↗ |
| Action | Inhibit | “a dual, irreversible EGFR- and HER2-inhibitor” NCT00425854 ↗ |
| Modality | Small molecule | “Four epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitors - afatinib, erlotinib, icotinib, and gefitinib - are available for first-line treatment of...” PMID 30584317 ↗ Nov 2018 |
| Route | Oral | “Once Daily Oral Dose” NCT00425854 ↗ |
| Target | EGFR | “a dual, irreversible EGFR- and HER2-inhibitor” NCT00425854 ↗ |