Drugs / Lapatinib
Lapatinib
also known as
GW572016 · lapatinib ditosylate · TYKERB · Tyverb · Lapatinib (Tykerb) · Lapatinib ditosylate monohydrate · GW572016 ditosylate salt · LAP · +3 more
Small molecule targets ABCB1, CYP2C8, CYP3A4, EGF, EGFR, ERBB2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Her2-receptor negative breast cancer 3 milestones | |||||
| Filed | EU (EMA) | Tyverb | Her2-receptor negative breast cancer | 2012-02-16 | “has submitted regulatory applications in Europe and the US related to Tykerb/ Tyverb (lapatinib)” gsk.com ↗ |
| Filed | US (FDA) | Tykerb | Her2-receptor negative breast cancer | 2012-02-16 | “has submitted regulatory applications in Europe and the US related to Tykerb/ Tyverb (lapatinib)” gsk.com ↗ |
| Filed | EU (EMA) | Tyverb | Her2-receptor negative breast cancer | 2011-04-15 | “it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Tyverb (lapatinib) in combination with paclitaxel” gsk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Tyverb | — | 2008-06-10 | europa.eu ↗ |
Trials 246 · started per year
today
EU approved 2008
2
4
19
20
23
37
21
33
17
21
16
10
8
3
5
2
1
2
1
1
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 05 trials | ||||||
| Phase 0 | NCT04135807 | Mar 2020 → Jan 2028 expected | anaplastic astrocytoma, anaplastic oligodendroglioma, brain oligodendroglioma, glioblastoma | Oliver Jonas | Recruiting | No outcome recorded |
| Phase 0 | NCT01427322 | Sep 2011 → Dec 2014 | epithelial neoplasm | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT01245660 | Jan → Oct 2011 | infiltrating bladder urothelial carcinoma | University Hospital, Bordeaux | Terminated | No outcome recorded Stop: Enrollment |
| Phase 0 | NCT00863122 | Jun 2009 → Aug 2014 | NF2-related schwannomatosis, acoustic neuroma, ear neoplasm | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Completed | No outcome recorded |
| Phase 0 | NCT00331630 | May → Nov 2006 | breast cancer | Northwestern University | Completed | No outcome recorded |
| Phase 161 trials | ||||||
| Phase 1 | NCT04608409 | Mar 2021 → May 2024 | ovarian cancer | Frederick R. Ueland, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT02101905 | Nov 2016 → Oct 2021 | anaplastic astrocytoma, anaplastic ependymoma, anaplastic oligodendroglioma, gliosarcoma +1 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02650752 | Jan 2016 → Jan 2021 | breast cancer, central nervous system cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02581124 | Oct 2015 → Apr 2016 | anemia due to chronic disorder | Akros Pharma Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02073916 | Oct 2013 → Dec 2018 | breast cancer | Jenny C. Chang, MD | Completed | No outcome recorded |
| Phase 1 | NCT01947023 | Sep 2013 → Apr 2026 overdue | thyroid gland carcinoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01705340 | Sep 2012 → May 2013 | HER2 positive breast carcinoma, esophageal cancer, gastric cancer, gastroesophageal junction adenocarcinoma +1 | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01434303 | Jan 2012 → Feb 2016 | HER2 positive breast carcinoma, invasive breast carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01454804 | Oct 2011 → Mar 2015 | high grade malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01290354 | Sep 2011 → Mar 2013 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01497626 | Sep 2011 → Dec 2015 | cancer | Georgetown University | Terminated | No outcome recorded |
| Phase 1 | NCT01300962 | Aug 2011 → Feb 2017 | breast cancer | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01454479 | Mar 2011 → Apr 2013 | endometrial cancer | Hung-Hsueh Chou | Unknown | No outcome recorded |
| Phase 1 | NCT01281163 | Jan 2011 → Dec 2013 | HER2 positive breast carcinoma, estrogen-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor negative breast cancer +1 | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT01245205 | Nov 2010 → Aug 2014 | HER2 positive breast carcinoma, male breast carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01238029 | Oct 2010 → Jul 2014 | HER2 positive breast carcinoma | Sponsor GmbH | Terminated | No outcome recorded |
| Phase 1 | NCT01184482 | Jun 2010 → Jun 2013 | colorectal cancer, head and neck cancer, lung cancer | Georgetown University | Completed | No outcome recorded |
| Phase 1 | NCT01087983 | Mar 2010 → Sep 2015 | — | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT02131506 | Dec 2009 → Jan 2016 | HER2 positive breast carcinoma | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Terminated | No outcome recorded |
| Phase 1 | NCT00963547 | Sep 2009 → Aug 2011 | breast cancer | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 1 | NCT00984425 | Sep 2009 → Jul 2012 | cancer | Istituto Clinico Humanitas | Completed | No outcome recorded |
| Phase 1 | NCT00804310 | Aug 2009 → Aug 2011 | cancer of unknown primary site | University of California, Davis | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT00849329 | Mar → Nov 2009 | breast neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00821054 | Mar 2009 → Mar 2011 | breast cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01133912 | Mar 2009 → Jun 2010 | breast cancer | Jungsil Ro | Completed | No outcome recorded |
| Phase 1 | NCT00790816 | Oct 2008 → Aug 2016 | breast neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00662636 | Aug 2008 → Dec 2014 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT00634088 | Jun 2008 → Jun 2010 | breast cancer | R-Pharm | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00632489 | May 2008 → Jan 2009 | breast cancer | SCRI Development Innovations, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00650910 | Apr 2008 → Jul 2009 | breast cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00513253 | Apr → May 2008 | — | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 1 | NCT00614978 | Jan 2008 → Jun 2011 | HER2 positive breast carcinoma, metastatic malignant neoplasm in the brain | Jules Bordet Institute | Completed | No outcome recorded |
| Phase 1 | NCT00623064 | Nov 2007 → Jun 2012 | renal pelvis/ureter urothelial carcinoma, urinary bladder cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 1 | NCT00543504 | Oct 2007 → Apr 2020 | cancer of unknown primary site | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00753207 | Oct 2007 → Nov 2008 | breast cancer | Cancer Trials Ireland | Completed | No outcome recorded |
| Phase 1 | NCT00536809 | Sep 2007 → Oct 2008 | colorectal neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00528281 | Sep 2007 → May 2009 | non-small cell lung carcinoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00516672 | Sep 2007 → Aug 2010 | renal cell carcinoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00544804 | Aug 2007 → Jun 2013 | breast cancer, metastatic malignant neoplasm | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT00495872 | Jun 2007 → Oct 2012 | cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00513058 | Jun 2007 → May 2010 | breast cancer | UNICANCER | Completed | No outcome recorded |
| Phase 1 | NCT00470847 | Apr 2007 → Dec 2009 | breast cancer, metastatic malignant neoplasm in the brain | Nancy Lin, MD | Completed | No outcome recorded |
| Phase 1 | NCT00447122 | Mar 2007 → Aug 2008 | malignant pancreatic neoplasm | Brown University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00424164 | Nov 2006 → Jun 2009 | breast cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 1 | NCT00352443 | Sep 2006 → Aug 2007 | cancer of unknown primary site, lymphoma | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 1 | NCT00439179 | Jul 2006 → Dec 2007 | malignant pancreatic neoplasm | Brown University | Completed | No outcome recorded |
| Phase 1 | NCT00316875 | May 2006 → Aug 2011 | breast cancer | Northwestern University | Completed | No outcome recorded |
| Phase 1 | NCT00388076 | Apr 2006 → Jul 2009 | breast neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00371488 | Apr 2006 → Dec 2007 | breast cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00313599 | Feb 2006 → Dec 2013 | breast cancer, central nervous system neoplasm, esophageal cancer, extragonadal germ cell tumor +5 | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1 | NCT00389922 | Dec 2005 → Apr 2009 | cancer of unknown primary site | University of California, Davis | Completed | No outcome recorded |
| Phase 1 | NCT00258050 | Nov 2005 → Feb 2007 | breast neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00317434 | Nov 2005 → Mar 2007 | ovarian carcinoma | University of Alabama at Birmingham | Terminated | No outcome recorded |
| Phase 1 | NCT00251433 | Sep 2005 → Jun 2010 | breast neoplasm | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT00158782 | Sep 2004 → Aug 2007 | renal cell carcinoma | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00295243 | Sep 2004 → Nov 2006 | high grade malignant neoplasm | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT00169533 | Aug 2004 → May 2009 | breast neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00462956 | Jun 2004 → Dec 2006 | breast neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00359190 | Jun 2004 → Jan 2008 | breast neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00085020 | Mar → Dec 2004 | breast cancer | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00148902 | Apr 2003 → Jan 2006 | breast neoplasm | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/218 trials | ||||||
| Phase 1/2 | NCT00455039 | Jul 2023 | breast cancer | University of New Mexico | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02230553 | Oct 2014 → Jul 2019 | colorectal cancer | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT01783756 | Jun 2013 → May 2019 | HER2 positive breast carcinoma, central nervous system cancer, male breast carcinoma | Jonsson Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT01658358 | Jul 2012 → Sep 2014 | breast cancer | China Medical University Hospital | Terminated | No outcome recorded |
| Phase 1/2 | NCT01589861 | Dec 2011 → Oct 2017 | breast cancer | Institut Paoli-Calmettes | Terminated | No outcome recorded |
| Phase 1/2 | NCT01395537 | Aug 2011 → Dec 2014 | esophageal adenocarcinoma, gastroesophageal junction adenocarcinoma | Case Comprehensive Cancer Center | Terminated | No outcome recorded |
| Phase 1/2 | NCT01495884 | Mar 2011 → Oct 2014 | HER2 positive breast carcinoma | Cancer Trials Ireland | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01138384 | Oct 2010 → May 2014 | breast cancer | NCIC Clinical Trials Group | Completed | No outcome recorded |
| Phase 1/2 | NCT01118975 | Mar 2010 → Oct 2012 | breast cancer, metastatic neoplasm | University of Maryland, Baltimore | Terminated | No outcome recorded |
| Phase 1/2 | NCT00953576 | Sep 2009 → Apr 2013 | prostate cancer | Dana-Farber Cancer Institute | Terminated | No outcome recorded |
| Phase 1/2 | NCT00952692 | Jul 2009 → Jul 2011 | breast cancer | Michael Morse, MD | Completed | No outcome recorded |
| Phase 1/2 | NCT00912275 | Nov 2008 → Mar 2015 | breast cancer | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 1/2 | NCT01044485 | Nov 2008 → Nov 2011 | breast cancer | Centre Georges Francois Leclerc | Completed | No outcome recorded |
| Phase 1/2 | NCT01172223 | Sep 2007 → Jan 2013 | breast cancer | Prof Dirk Elling | Completed | No outcome recorded |
| Phase 1/2 | NCT00450892 | Feb 2007 → Jul 2013 | breast cancer | European Organisation for Research and Treatment of Cancer - EORTC | Completed | No outcome recorded |
| Phase 1/2 | NCT00316407 | Aug 2005 → Nov 2009 | female breast carcinoma, ovarian carcinoma | Swedish Medical Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00099060 | Dec 2004 → Nov 2007 | central nervous system neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1/2 | NCT00095940 | Oct 2004 → Jul 2010 | anaplastic astrocytoma, childhood brain stem glioma, childhood ependymoma, childhood medulloblastoma +3 | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2128 trials · 7 met primary · 18 missed | ||||||
| Phase 2 | NCT04591431 | Oct 2020 → Dec 2024 | breast cancer, digestive system cancer, non-small cell lung carcinoma | Fondazione per la Medicina Personalizzata | Unknown | Met primary |
| Phase 2 | NCT02788201 | Mar 2017 → Oct 2019 | urinary bladder cancer, urothelial carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT03768375 | Nov 2016 → Dec 2020 | extrahepatic bile duct carcinoma, gallbladder cancer | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT03273595 | Jul 2016 → Jul 2019 | breast cancer | Xijing Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02836847 | Jul 2016 → Dec 2019 | cholangiocarcinoma, gallbladder cancer | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 2 | NCT02362958 | Jan 2015 → May 2020 | HER2 positive breast carcinoma | Sun Yat-sen University | Completed | No outcome recorded |
| Phase 2 | NCT02342587 | Dec 2014 → Jan 2016 | carcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02238509 | Nov 2014 → Oct 2017 | breast cancer | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 2 | NCT02142036 | May 2014 → Aug 2018 | metastatic malignant neoplasm | Oslo University Hospital | Completed | Met primary |
| Phase 2 | NCT01934894 | May 2014 → Feb 2016 | metastatic malignant neoplasm in the brain | SCRI Development Innovations, LLC | Terminated | No outcome recorded |
| Show all 128 trials opens the full record — a long page | ||||||
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT03085368 | Mar 2017 → May 2018 | HER2 positive breast carcinoma | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT00949455 | Mar 2009 → Jul 2015 | urinary bladder cancer | Queen Mary University of London | Unknown | No outcome recorded |
| Phase 2/3 | NCT00450203 | Oct 2007 → Dec 2017 | gastroesophageal cancer | Medical Research Council | Unknown | Missed primary |
| Phase 323 trials · 5 met primary · 9 missed | ||||||
| Phase 3 | NCT03784014 | Oct 2019 → Dec 2023 | soft tissue sarcoma | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 3 | NCT01526369 | Feb 2012 → Nov 2015 | breast cancer | Cancer Trials Ireland | Completed | No outcome recorded |
| Phase 3 | NCT01619111 | Feb 2012 → Jan 2022 | HER2 positive breast carcinoma, Her2-receptor negative breast cancer | University of Ulm | Completed | Missed primary |
| Phase 3 | NCT00968968 | Jan 2010 → Feb 2014 | cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00820222 | Apr 2009 → Jun 2012 | metastatic malignant neoplasm in the brain | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT00770809 | Feb 2009 → Jan 2014 | male breast carcinoma | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 3 | NCT00680901 | Jun 2008 → Sep 2012 | digestive system neoplasm | Novartis Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT00553358 | Jan 2008 → May 2010 | breast neoplasm | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02394496 | Nov 2007 → Dec 2016 | breast cancer | Consorzio Oncotech | Unknown | No outcome recorded |
| Phase 3 | NCT00567554 | Oct 2007 → Aug 2011 | breast cancer | GBG Forschungs GmbH | Completed | Mixed |
| Phase 3 | NCT00508274 | Jul 2007 → Dec 2015 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT00486668 | Jul 2007 → Jun 2012 | invasive breast carcinoma | NSABP Foundation Inc | Unknown | No outcome recorded |
| Phase 3 | NCT00486954 | Jul 2007 → Jan 2012 | digestive system neoplasm | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00490139 | May 2007 → Dec 2013 | breast neoplasm | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00424255 | Dec 2006 → Mar 2013 | head and neck neoplasm | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00390455 | Sep 2006 → Jul 2014 | HER2 positive breast carcinoma, Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, progesterone-receptor positive breast cancer | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 3 | NCT00374322 | Aug 2006 → Sep 2011 | breast neoplasm | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00281658 | Jan 2006 → Jun 2010 | breast cancer | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00272987 | Dec 2005 → Jul 2009 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00320385 | Nov 2005 → Jun 2007 | breast cancer | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00078572 | Mar 2004 → Apr 2006 | breast cancer | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00075270 | Jan 2004 → Oct 2006 | breast cancer | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00073528 | Dec 2003 → Jun 2008 | breast neoplasm | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT01328054 | Dec 2011 → Mar 2015 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT02551718 | Sep 2015 → Jun 2020 | acute leukemia of ambiguous lineage, acute lymphoblastic leukemia | University of Washington | Completed | No outcome recorded |
| — | NCT02158507 | Sep 2014 → Jul 2021 | triple-negative breast carcinoma | University of Alabama at Birmingham | Completed | No outcome recorded |
| — | NCT01636908 | Aug 2011 → Jan 2018 | cancer | Amsterdam UMC, location VUmc | Completed | No outcome recorded |
| — | NCT01190241 | Aug 2010 → Dec 2017 | cancer, metastatic neoplasm | Amsterdam UMC, location VUmc | Terminated | No outcome recorded |
| — | NCT00555152 | Aug 2009 → Aug 2014 | HER2 positive breast carcinoma, ductal breast carcinoma in situ | National Cancer Institute (NCI) | Completed | No outcome recorded |
| — | NCT00857714 | Apr 2009 → Aug 2010 | ductal breast carcinoma in situ | Indiana University | Terminated | No outcome recorded Stop: Enrollment |
| Phase not stated1 trial | ||||||
| — | NCT00338247 | Jul 2006 → Mar 2015 | breast cancer | Novartis | Approved for marketing | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 0 | NCT01875666 Comparator | Aug 2013 → Dec 2016 | breast neoplasm | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01471847 Comparator | Feb → Jun 2012 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01304784 Background | Jan 2011 → Apr 2014 | carcinoma | Merrimack Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01199367 Background | Dec 2010 → Dec 2012 | breast cancer | Kyowa Kirin, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT00807859 Background | Mar 2009 → Feb 2014 | female breast carcinoma, metastatic malignant neoplasm | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT00682279 Comparator | Sep 2008 → Mar 2011 | cancer | GlaxoSmithKline | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00367471 Comparator | Dec 2006 → Dec 2010 | breast cancer | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/2 | NCT02422199 Comparator | May 2015 → Oct 2016 | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT02338245 Comparator | Dec 2014 → May 2016 | breast cancer | ASLAN Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02294786 Background | Dec 2014 → Oct 2017 | cancer | Novartis Pharmaceuticals | Terminated | Missed primary |
| Phase 2 | NCT02213042 Comparator | Oct 2014 → Jun 2020 | breast cancer | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01711658 Comparator | Mar 2013 → Dec 2020 | head and neck carcinoma | Radiation Therapy Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT01306045 Comparator | Feb 2011 → Feb 2014 | non-small cell lung carcinoma, small cell lung carcinoma, thymic carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT01068704 Comparator | Jun → Dec 2010 | breast cancer | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01128543 Comparator | Apr 2009 → Mar 2012 | cancer | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00777101 Comparator | Feb 2009 → Mar 2011 | breast cancer | Puma Biotechnology, Inc. | Completed | Missed primary |
| Phase 2 | NCT00826267 Comparator | Jan 2009 → Aug 2011 | breast neoplasm | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 2 | NCT00657137 Background | Apr 2008 → Sep 2009 | breast cancer | Tragara Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT03500380 Comparator | Apr 2018 → Jul 2024 | HER2 positive breast carcinoma | RemeGen Co., Ltd. | Unknown | Met primary |
| Phase 2/3 | NCT01426880 Background | Aug 2011 → May 2013 | HER2 positive breast carcinoma, breast mucinous carcinoma, female breast carcinoma, inflammatory breast carcinoma +1 | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 3 | NCT06313983 Comparator | Jan 2022 → Dec 2025 overdue | breast cancer | Tianjin Hemay Pharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 3 | NCT03523585 Comparator | Aug 2018 → Jun 2022 | breast cancer | Daiichi Sankyo | Completed | Met primary |
| Phase 3 | NCT04185649 Comparator | Jul 2018 → Jul 2020 | HER2 positive breast carcinoma | Bio-Thera Solutions | Unknown | No outcome recorded |
| Phase 3 | NCT03262935 Comparator | Dec 2017 → Mar 2021 | breast cancer | Byondis B.V. | Completed | Met primary |
| Phase 3 | NCT03080805 Comparator | May 2017 → Mar 2019 | HER2 positive breast carcinoma | Jiangsu HengRui Medicine Co., Ltd. | Unknown | Met primary |
| Phase 3 | NCT03084939 Comparator | Apr 2017 → Nov 2018 | breast cancer | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT01808573 Comparator | Mar 2013 → Sep 2018 | HER2 positive breast carcinoma | Puma Biotechnology, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01160211 Comparator | May 2011 → Mar 2016 | breast neoplasm | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00829166 Comparator | Feb 2009 → Jul 2012 | breast cancer | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT00667251 Comparator | Oct 2008 → Aug 2012 | female breast carcinoma | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00688194 Comparator | May 2008 → May 2013 | breast cancer | Gruppo Italiano Mammella (GIM) | Unknown | No outcome recorded |
| — | NCT02208583 Comparator | Jun 2014 → Dec 2016 | hormone-resistant prostate carcinoma | Tianjin Medical University Cancer Institute and Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 24
| Date | Issuer | Release |
|---|---|---|
| 2024-12-13 | RemeGen Co., Ltd. | Results 2024 SABCS｜Results Unveiled for the Phase III Study of Disitamab Vedotin in Treating HER2-Positive Advanced Breast Cancer with Liver Metastasis remegen.com ↗
DV significantly improved progression-free survival (PFS) versus Lapatinib plus Capecitabine |
| 2020-12-11 | Puma Biotechnology, Inc. | Results Puma Biotechnology Presents Efficacy and Safety Outcomes from the Phase III NALA Trial at the 2020 SABCS Results show improved CNS outcomes with neratinib-based regimens in the treatment and prevention of CNS metastases from HER2-positive breast cancer pumabiotechnology.com ↗
The NALA study met its primary endpoint, with the neratinib arm having significantly improved PFS vs. the lapatinib arm (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.63-0.93; stratified log-rank P = .0059; mean PFS 8.8 mo vs. 6.6 mo). |
| 2020-09-30 | NATCO Pharma Ltd. | Regulatory NATCO announces launch of breast cancer medicine Lapatinib Tablets in the U.S. natcopharma.co.in ↗
NATCO received the final approval for its Abbreviated New Drug Application (ANDA) from the U.S. Federal Drug Administration (USFDA). |
| 2020-09-30 | Lupin Limited | Regulatory Lupin Launches Lapatinib Tablets lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced today the launch of Lapatinib Tablets, 250 mg, after Lupin’s alliance partner Natco Pharma Ltd received final approval for its ANDA from the United States Food and Drug Administration (U.S. FDA). |
| 2018-12-17 | Puma Biotechnology, Inc. | Results Puma Biotechnology Announces Top Line Results of the Phase III NALA Trial of Neratinib in Patients with HER2-Positive Metastatic Breast Cancer pumabiotechnology.com ↗
For the primary analysis of centrally confirmed PFS, treatment with neratinib plus capecitabine resulted in a statistically significant improvement in centrally confirmed PFS (p=0.0059) compared to treatment with lapatinib plus capecitabine. |
| 2014-06-01 | GlaxoSmithKline | Results GSK announces Phase III ALTTO results for anti-HER2 therapy combination in the adjuvant breast cancer treatment setting gsk.com ↗
The results showed that at four years, 88 percent of women lived without their disease returning (4-year DFS) in the lapatinib plus trastuzumab arm and 86 percent in the trastuzumab arm [HR 0.84 (97.5% CI, 0.70-1.02; p=0.048)]. |
| 2013-08-14 | GlaxoSmithKline | Regulatory GSK receives marketing authorisation from the European Commission for additional indication: Tyverb™ (lapatinib) gsk.com ↗
GlaxoSmithKline announced today that the European Commission has granted an additional indication for Tyverb™ (lapatinib) to be used in combination with trastuzumab. |
| 2013-06-28 | GlaxoSmithKline | Regulatory Regulatory Update - GSK receives positive CHMP opinions for Tafinlar® (dabrafenib) and Tyverb® (lapatinib) gsk.com ↗ |
| 2013-06-03 | GlaxoSmithKline | Results GSK announces Phase III data for TYKERB/TYVERB® (lapatinib) in combination with chemotherapy for advanced HER2-positive gastric cancer gsk.com ↗
Issued: London UK GlaxoSmithKline (GSK) plc today announced that its study of TYKERB/TYVERB® (lapatinib) in combination with chemotherapy in patients with HER2-positive advanced gastric cancer did not meet the primary endpoint of improved overall survival (OS) compared to chemotherapy alone. |
| 2012-07-12 | GlaxoSmithKline | Regulatory US Regulatory Update – Tykerb® (lapatinib) gsk.com ↗
GlaxoSmithKline plc announced today that it has withdrawn a supplemental New Drug Application to the US Food and Drug Administration (FDA) for Tykerb (lapatinib) in combination with trastuzumab for the treatment of patients with HER2 (ErbB2)-positive metastatic breast cancer who have received prior trastuzumab therapy. |
| 2012-06-03 | AbbVie | Results ImmunoGen, Inc. Announces Results from Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial abbvie.com ↗
Treatment with trastuzumab emtansine significantly improved progression-free survival (PFS) compared to treatment with lapatinib plus capecitabine, as assessed by an independent review committee. |
| 2012-03-30 | AbbVie | Results ImmunoGen, Inc. Announces Positive Results in Trastuzumab Emtansine (T-DM1) EMILIA Phase III Trial abbvie.com ↗
Roche announced today that the EMILIA patients who were randomized to treatment with trastuzumab emtansine had a significantly longer duration of progression-free survival (PFS) than those randomized to treatment with the control therapy, lapatinib (Tykerb®) plus capecitabine (Xeloda®). |
| 2012-02-16 | GlaxoSmithKline | Regulatory EU and US Regulatory Update – Tykerb/Tyverb® (lapatinib) gsk.com ↗
GlaxoSmithKline announced today that it has submitted regulatory applications in Europe and the US related to Tykerb/ Tyverb (lapatinib) and its use in combination with trastuzumab to treat patients with HER2 (ErbB2)-positive metastatic breast cancer. |
| 2011-12-08 | GlaxoSmithKline | Results GSK presents phase lll data for lapatinib at San Antonio breast cancer symposium gsk.com ↗
Therefore, although an improvement in disease-free survival in favor of lapatinib was observed, this result did not meet the prespecified criteria for statistical significance. |
| 2011-09-09 | GlaxoSmithKline | Results Lapatinib clinical trial update gsk.com ↗
However, the committee has indicated that the lapatinib alone arm is unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival. |
| 2011-04-15 | GlaxoSmithKline | Regulatory Regulatory Update - Tyverb® lapatinib gsk.com ↗
it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Tyverb (lapatinib) |
| 2010-12-09 | GlaxoSmithKline | Results Phase III study in HER2-positive advanced breast cancer shows overall survival benefit when Tykerb is combined with paclitaxel gsk.com ↗
In a blinded, randomised, Phase III study, women with previously untreated HER2-positive metastatic breast cancer achieved a statistically-significant improvement in overall survival when treated with an investigational combination of Tykerb® (lapatinib) plus paclitaxel, a widely used chemotherapy agent. |
| 2010-12-09 | GlaxoSmithKline | Results Data from Tykerb investigational phase III studies in neo-adjuvant HER2-positive breast cancer presented at breast cancer symposium gsk.com ↗
Topline results were presented today from two Phase III studies examining the effect of Tykerb (lapatinib) in the neo-adjuvant setting of HER2-positive breast cancer. |
| 2010-06-22 | GlaxoSmithKline | Regulatory GlaxoSmithKline receives EU authorisation for a new therapeutic indication for Tyverb® (lapatinib) gsk.com ↗
GlaxoSmithKline (GSK) confirmed today that the European Commission (EC) has granted a variation to the conditional marketing authorisation for Tyverb® (lapatinib) in the European Union for a new therapeutic indication. |
| 2010-02-18 | GlaxoSmithKline | Regulatory GSK receives positive opinions in Europe for Tyverb® (lapatinib) and Votrient™ (pazopanib) gsk.com ↗
The CHMP has issued a positive opinion for the authorisation of a new therapeutic indication for Tyverb® (lapatinib) in the European Union. |
| 2010-01-28 | GlaxoSmithKline | Regulatory GSK’s Tykerb® receives accelerated approval for first-line combination treatment of hormone receptor positive, HER2+/ErbB2+ metastatic breast cancer gsk.com ↗
GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using Tykerb® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer. |
| 2009-12-10 | GlaxoSmithKline | Results GSK study showed targeted therapy combination achieved 14 month overall survival in patients with advanced breast cancer gsk.com ↗
In a clinical study, women with an aggressive form of breast cancer experienced a median survival of 14 months when treated with an investigational combination of TYKERB® (lapatinib) plus HERCEPTIN® (trastuzumab). |
| 2009-03-31 | GlaxoSmithKline | Regulatory GSK submits Tyverb®/Tykerb® (lapatinib) for first-line treatment of metastatic breast cancer in Europe, US gsk.com ↗
GlaxoSmithKline (GSK) today announced the submission of two simultaneous regulatory applications to expand the use of Tyverb®/Tykerb® (lapatinib). |
| 2009-03-04 | GlaxoSmithKline | Regulatory NICE refuses funding for advanced breast cancer treatment, Tyverb® (lapatinib) gsk.com ↗ |
All press releases naming this drug 24 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 281 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lapatinib | “The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs (Temozolomide, Lomustine, Irinotecan, Carboplatin,...” NCT04135807 ↗273“Participants who have erythroblastic leukemia viral oncogene homolog 2 (ERBB2) gene mutation will receive a drug called lapatinib, which inhibits some proteins that are thought...” NCT02208583 ↗ “This study was conducted to determine the safety and pharmacokinetics (PK) of the combination of lapatinib, a Her1 and 2 inhibitor, and everolimus and to describe its...” PMID 24057042 ↗ Sep 2013 “Lapatinib (GW572016) is an orally active small molecule that reversibly inhibits ErbB1 and ErbB2 tyrosine kinases” NCT02394496 ↗ “Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet.” NCT00371488 ↗ “Lapatinib is an oral, small molecule, dual tyrosine kinase inhibitor of HER2 and EGFR.” NCT00486668 ↗ “Subjects will self-administer lapatinib 1500 mg orally once daily.” NCT00462956 ↗ “Lapatinib 750 mg/day p.o. continuously for 18 weeks” NCT01426880 ↗ “Drug: Gefitinib Drug: Lapatinib Drug: Everolimus” NCT03768375 ↗ “Lapatinib either at 750, 1000, 1250 or 1500 mgs” NCT00169533 ↗ “Lapatinib was administered once daily orally.” NCT00528281 ↗ |
| Known as | GW572016 | “A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination With Weekly Paclitaxel Versus Weekly Paclitaxel Alone in the Second Line Treatment...” NCT00486954 ↗21“The primary objective of this phase I study is to determine the safety, tolerability and optimal tolerated regimen of GW572016 when combined with gemcitabine and with the...” NCT00439179 ↗ “To determine the response rate (complete response and partial response) of tamoxifen (tamoxifen citrate) and GW572016 (lapatinib ditosylate) in women with hormone refractory,...” NCT00118157 ↗ “Lapatinib (GW572016) is an orally active small molecule that reversibly inhibits ErbB1 and ErbB2 tyrosine kinases” NCT02394496 ↗ “Lapatinib (GW572016) is a potent small molecule, reversible inhibitor of both EGFR and ErbB2 tyrosine kinases” NCT00367471 ↗ “Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer” NCT00374322 ↗ “Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length)” NCT00295243 ↗ “Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy” NCT00044343 ↗ “dual tyrosine kinase inhibitor GW572016 (Lapatinib)” NCT00820924 ↗ “oral topotecan (SK&F-104864); lapatinib (GW572016)” NCT00682279 ↗ “oral GW572016 as Single Agent Therapy” NCT00051103 ↗ |
| Known as | GW572016 ditosylate salt | “GW572016 ditosylate salt (lapatinib) will be given as 250 mg tablets via oral route” NCT00359190 ↗ |
| Known as | LAP | “Lapatinib ditosylate (LAP), a dual anti-epidermal growth factor receptor (EGFR) and anti-HER2 tyrosine kinase inhibitor with preclinical activity against GC, has been approved...” PMID 25694417 ↗ Feb 2015 |
| Known as | Lapatinib (Lap) | “Lapatinib (Lap)” NCT03262935 ↗ |
| Known as | Lapatinib (Tykerb) | “Lapatinib (Tykerb)” NCT02158507 ↗1“Lapatinib: Tykerb” NCT00486954 ↗ |
| Known as | lapatinib ditosylate | “Determine the maximum tolerated dose and recommended doses of lapatinib ditosylate when administered with gemcitabine hydrochloride and cisplatin, and determine on the basis of...” NCT00623064 ↗13“PRIMARY OBJECTIVES: I. The primary objective of this study is to estimate the objective response rate (complete response \[CR\] + partial response \[PR\]) in patients with...” NCT00114283 ↗ “This phase II trial studies the effectiveness of lapatinib ditosylate (lapatinib) together with trastuzumab in treating patients with HER2-negative breast cancer that carries...” NCT01557764 ↗ “lapatinib (lapatinib ditosylate) therapy at the dose of 1000 mg” NCT00555152 ↗ “concurrent lapatinib (lapatinib ditosylate) and radiotherapy” NCT01868503 ↗ “Patients receive oral lapatinib ditosylate once daily.” NCT00967031 ↗ “lapatinib (lapatinib ditosylate)” NCT01705340 ↗ “Drug: lapatinib ditosylate” NCT00482391 ↗ “Drug: Lapatinib Ditosylate” NCT00118157 ↗ “Drug: Lapatinib Ditosylate” NCT00770809 ↗ “Drug: lapatinib ditosylate” NCT01123473 ↗ |
| Known as | Lapatinib ditosylate monohydrate | “Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet.” NCT00371488 ↗1“Each tablet contained 405mg of Lapatinib ditosylate monohydrate, equivalent to 250mg Lapatinib free base” NCT02294786 ↗ |
| Known as | lapatinib free base | “Tablets contain 405mg of lapatinib ditosylate monohydrate, equivalent to 250mg lapatinib free base per tablet.” NCT00371488 ↗ |
| Known as | lapatinib tosylate | “oral lapatinib tosylate” NCT00688194 ↗ |
| Known as | TYKERB | “This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib (TYKERB) in the first and second-line setting in...” NCT00709761 ↗7“TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation” NCT01711658 ↗ “GlaxoSmithKline markets the drug lapatinib under the propriety names Tykerb (mostly US) and Tyverb (mostly Europe).” PMID 26571496 ↗ Nov 2015 “Lapatinib (also called Tyverb or Tykerb) will be compared with another drug trastuzumab” NCT01205217 ↗ “Lapatinib (Tykerb™) blocks signals that stimulate HER2-positive breast cancers to grow.” NCT00721630 ↗ “A Phase I Study of Lapatinib (Tykerb) Plus Ixabepilone (Ixempra)” NCT01454479 ↗ “Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)” NCT00388076 ↗ “Lapatinib (GW572016, Tykerb)” NCT01172223 ↗ |
| Known as | Tyverb | “Pilot Study of Lapatinib (Tyverb®) in Neoadjuvant Treatment for Patients With Locally Bladder Carcinoma Before Cystectomy” NCT01245660 ↗3“GlaxoSmithKline markets the drug lapatinib under the propriety names Tykerb (mostly US) and Tyverb (mostly Europe).” PMID 26571496 ↗ Nov 2015 “Lapatinib (also called Tyverb or Tykerb) will be compared with another drug trastuzumab” NCT01205217 ↗ “Lapatinib (Tyverb™)” NCT01495884 ↗ |
| Action | Inhibit | “dual kinase inhibitor” NCT00062686 ↗ |
| Modality | Small molecule | “Lapatinib is a small molecule, dual tyrosine kinase inhibitor” PMID 18188694 ↗ Jan 2008 |
| Route | Oral | “Oral Lapatinib” NCT00044343 ↗ |
| Target | EGFR | “dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor type 2 (HER2)” PMID 18188694 ↗ Jan 2008 |