Lapatinib
Information
- Drug Name
- Lapatinib
- Description
- Entry(CIViC)
- 33
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In-vitro studies using ERBB2 over-expressing breas... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| In light of results showing increased PFS using mA... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| This Phase III trial compared the activity of lapa... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | false | CIViC Evidence | detail |
| This Phase III study (EGF104900) was motivated by ... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| TyTAN, a Phase III study in Asian patients, looked... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| This Phase III trial took patients with locally ad... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| Colon cancer patient derived xenografts with HER2 ... | ERBB2 |
ERBB2 p.Val842Ile (p.V842I) ( ENST00000541774.5, ENST00000584450.5, ENST00000584601.5, ENST00000269571.10, ENST00000406381.6, ENST00000445658.6 ) ERBB2 p.Val842Ile (p.V842I) ( ENST00000584450.5, ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Colon cancer patient derived xenografts with HER2 ... | ERBB2 |
ERBB2 p.Leu755Ser (p.L755S) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Leu755Ser (p.L755S) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Colon cancer patient derived xenografts with HER2 ... | ERBB2 |
ERBB2 p.Val777Leu (p.V777L) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Val777Leu (p.V777L) ( ENST00000584601.5, ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Colon cancer patient derived xenografts with HER2 ... | ERBB2 |
ERBB2 p.Leu866Met (p.L866M) ( ENST00000541774.5, ENST00000584601.5, ENST00000269571.10, ENST00000445658.6, ENST00000584450.5, ENST00000406381.6 ) ERBB2 p.Leu866Met (p.L866M) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Colon cancer patient derived xenografts with HER2 ... | ERBB2 | ERBB2 S310F/Y ERBB2 S310F/Y | Sensitivity | true | CIViC Evidence | detail |
| In a randomized open label phase 3 study (NCT00553... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| The HER2 breast cancer cell line KPL4 with PIK3CA ... | PIK3CA |
PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) PIK3CA p.His1047Arg (p.H1047R) ( ENST00000263967.4, ENST00000643187.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| Phase 2 study in 27 patients with HER2 positive (I... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| 18 advanced progressing chordoma patients entered ... | EGFR | EGFR EXPRESSION EGFR EXPRESSION | Sensitivity | true | CIViC Evidence | detail |
| Cell proliferation analysis showed that the ERBB2-... | ERBB2 |
ERBB2 p.Thr862Ala (p.T862A) ( ENST00000584450.5, ENST00000584601.5, ENST00000541774.5, ENST00000445658.6, ENST00000269571.10, ENST00000406381.6 ) ERBB2 p.Thr862Ala (p.T862A) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Cell proliferation analysis showed that the ERBB2-... | ERBB2 |
ERBB2 p.Val773Ala (p.V773A) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Val773Ala (p.V773A) ( ENST00000269571.10, ENST00000584601.5, ENST00000584450.5, ENST00000445658.6, ENST00000406381.6, ENST00000541774.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Cell proliferation analysis showed that the ERBB2-... | ERBB2 |
ERBB2 p.Asn857Ser (p.N857S) ( ENST00000445658.6, ENST00000269571.10, ENST00000584601.5, ENST00000584450.5, ENST00000406381.6, ENST00000541774.5 ) ERBB2 p.Asn857Ser (p.N857S) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Cell proliferation analysis showed that the ERBB2-... | ERBB2 |
ERBB2 p.His878Tyr (p.H878Y) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.His878Tyr (p.H878Y) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| Case report of a 60-year old patient with p16 posi... | ERBB2 | ERBB2 OVEREXPRESSION ERBB2 OVEREXPRESSION | Sensitivity | true | CIViC Evidence | detail |
| In an in vitro study using NCI-H1666 cells (wildty... | EGFR |
EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Thr790Met (p.T790M) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| The L755S mutation was shown to confer resistance ... | ERBB2 |
ERBB2 p.Leu755Ser (p.L755S) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Leu755Ser (p.L755S) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In an in vitro study using NCI-H1666 cells (wildty... | EGFR |
EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) EGFR p.Leu858Arg (p.L858R) ( ENST00000275493.7, ENST00000450046.2, ENST00000455089.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In MCF10A cell lines, the D769H mutation was shown... | ERBB2 |
ERBB2 p.Asp769His (p.D769H) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Asp769His (p.D769H) ( ENST00000269571.10, ENST00000584450.5, ENST00000584601.5, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| In MCF10A cell lines retrovirally transduced with ... | ERBB2 |
ERBB2 p.Leu755_Thr759del (p.L755_T759del) ( ENST00000406381.6, ENST00000445658.6, ENST00000269571.10, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) ERBB2 p.Leu755_Thr759del (p.L755_T759del) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| MCF10A cells transduced with ERBB2 harboring an R6... | ERBB2 |
ERBB2 p.Arg678Gln (p.R678Q) ( ENST00000584450.5, ENST00000584601.5, ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5 ) ERBB2 p.Arg678Gln (p.R678Q) ( ENST00000269571.10, ENST00000406381.6, ENST00000445658.6, ENST00000541774.5, ENST00000584450.5, ENST00000584601.5 ) |
Sensitivity | true | CIViC Evidence | detail |
| ERBB4 was the most commonly mutated protein tyrosi... | ERBB4 | ERBB4 MUTATION ERBB4 MUTATION | Sensitivity | true | CIViC Evidence | detail |
| In non-HER2 amplified cell lines, sensitivity to H... | NRG1 | NRG1 EXPRESSION NRG1 EXPRESSION | Sensitivity | true | CIViC Evidence | detail |
| Cytoplasmic localization of p27 (CDKN1B) leads to ... | CDKN1B | CDKN1B CYTOPLASMIC MISLOCALIZATION CDKN1B CYTOPLASMIC MISLOCALIZATION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In 48 patients with advanced gastric cancer, retro... | PTEN |
PTEN DELETION ( ENST00000371953.8 ) PTEN DELETION ( ENST00000371953.8 ) |
Resitance or Non-Reponse | true | CIViC Evidence | detail |
| ERBB4 protein expression was identified in breast ... | ERBB4 | ERBB4 EXPRESSION ERBB4 EXPRESSION | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| In this phase 2 trial, treatment-naive, ERBB2-posi... | ERBB2 |
ERBB2 AMPLIFICATION ( ENST00000269571.10 ) ERBB2 AMPLIFICATION ( ENST00000269571.10 ) |
Sensitivity | true | CIViC Evidence | detail |
| Serum and tissue levels of HER2 (ERBB2) were analy... | ERBB2 | ERBB2 SERUM LEVELS ERBB2 SERUM LEVELS | Sensitivity | true | CIViC Evidence | detail |
| Melanoma cells expressing mutationally activated E... | ERBB4 | ERBB4 R544W | Sensitivity | true | MMMP | detail |
| Melanoma cells expressing mutationally activated E... | ERBB4 | ERBB4 E563K | Sensitivity | true | MMMP | detail |
| Melanoma cells expressing mutationally activated E... | ERBB4 | ERBB4 E317K | Sensitivity | true | MMMP | detail |
| Melanoma cells expressing mutationally activated E... | ERBB4 | ERBB4 E452K | Sensitivity | true | MMMP | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT03784014 | Active, not recruiting | Phase 3 | Molecular Profiling of Advanced Soft-tissue Sarcomas | October 19, 2019 | October 2025 |
| NCT01612351 | Active, not recruiting | Phase 2 | Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery | June 2012 | November 2031 |
| NCT00470704 | Active, not recruiting | Phase 2 | Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer | May 14, 2007 | December 30, 2024 |
| NCT03500380 | Active, not recruiting | Phase 2/Phase 3 | A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases | April 24, 2018 | December 31, 2024 |
| NCT03523585 | Active, not recruiting | Phase 3 | DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] | August 1, 2018 | May 1, 2025 |
| NCT01306045 | Active, not recruiting | Phase 2 | Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies | February 8, 2011 | December 31, 2024 |
| NCT01273610 | Active, not recruiting | Phase 2 | Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer | April 20, 2011 | February 22, 2025 |
| NCT04591431 | Active, not recruiting | Phase 2 | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy | October 7, 2020 | June 2025 |
| NCT00999804 | Active, not recruiting | Phase 2 | Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy | October 2011 | January 2024 |
| NCT02101905 | Active, not recruiting | Phase 1 | Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma | March 13, 2014 | October 19, 2024 |
| NCT01947023 | Active, not recruiting | Phase 1 | Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery | September 27, 2013 | December 1, 2024 |
| NCT00680901 | Active, not recruiting | Phase 3 | LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib | June 4, 2008 | January 22, 2025 |
| NCT00320385 | Completed | Phase 3 | Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer | November 2005 | October 2010 |
| NCT00320411 | Completed | Phase 2 | GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer | November 28, 2005 | April 1, 2009 |
| NCT00350727 | Completed | Phase 2 | Pazopanib In Combination With Lapatinib In Adult Patients With Relapsed Malignant Glioma | December 2006 | December 2009 |
| NCT00359190 | Completed | Phase 1 | Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer | June 29, 2004 | January 9, 2008 |
| NCT00367471 | Completed | Phase 1 | Combination Of Lapatinib With Carboplatin, Paclitaxel, and With or Without Trastuzumab In Metastatic Breast Cancer. | December 7, 2006 | September 12, 2019 |
| NCT00374322 | Completed | Phase 3 | Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer | August 2006 | July 2013 |
| NCT00388076 | Completed | Phase 1 | Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB) | April 28, 2006 | July 21, 2009 |
| NCT00404066 | Completed | Phase 2 | Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer | October 2006 | March 2011 |
| NCT00422903 | Completed | Phase 2 | Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer | April 2007 | April 2011 |
| NCT00424255 | Completed | Phase 3 | Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery | December 2006 | November 2013 |
| NCT00429299 | Completed | Phase 2 | Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer | August 2006 | June 2012 |
| NCT00436644 | Completed | Phase 2 | Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin | March 2007 | November 2012 |
| NCT00444535 | Completed | Phase 2 | Lapatinib and Bevacizumab for Metastatic Breast Cancer | February 27, 2007 | June 19, 2020 |
| NCT00470847 | Completed | Phase 1 | Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer | April 2007 | June 2012 |
| NCT00477464 | Completed | Phase 2 | Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer | June 2007 | December 2010 |
| NCT00486954 | Completed | Phase 3 | Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer | July 2007 | October 2012 |
| NCT00490139 | Completed | Phase 3 | ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D | May 16, 2007 | July 1, 2021 |
| NCT00495872 | Completed | Phase 1 | Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor | June 2007 | |
| NCT02073916 | Completed | Phase 1 | T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer | October 2013 | December 2018 |
| NCT00073528 | Completed | Phase 3 | Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer | December 9, 2003 | March 22, 2018 |
| NCT00089999 | Completed | Phase 2 | Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer | June 2004 | March 2008 |
| NCT00105950 | Completed | Phase 2 | Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer | March 2005 | May 2010 |
| NCT00111787 | Completed | Phase 2 | Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer | April 11, 2005 | November 1, 2006 |
| NCT00148902 | Completed | Phase 1 | Effects Of GW572016 In Combination With Docetaxel (TAXOTERE) | April 28, 2003 | January 21, 2006 |
| NCT00158782 | Completed | Phase 1 | Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients | September 28, 2004 | August 21, 2007 |
| NCT00206427 | Completed | Phase 2 | Neoadjuvant GW572016 to Treat Breast Cancer | August 2004 | February 2012 |
| NCT00258050 | Completed | Phase 1 | To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients | November 21, 2005 | February 8, 2007 |
| NCT00263588 | Completed | Phase 2 | Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer | December 2, 2005 | March 15, 2018 |
| NCT00299286 | Completed | Phase 2 | Short-term Presurgical Study to Assess Molecular Predictors of Lapatinib's Effects in Primary Breast Cancer | June 2007 | August 2011 |
| NCT00313599 | Completed | Phase 1 | Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors | February 2006 | December 2013 |
| NCT00548184 | Completed | Phase 2 | Lapatinib and Trastuzumab With or Without Endocrine Therapy | May 2008 | January 2014 |
| NCT00553358 | Completed | Phase 3 | Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study | January 5, 2008 | December 23, 2019 |
| NCT00558103 | Completed | Phase 2 | Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer | December 2007 | December 2011 |
| NCT00574171 | Completed | Phase 2 | Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma | September 2007 | August 2009 |
| NCT00632489 | Completed | Phase 1 | LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients | May 2008 | July 2011 |
| NCT00650910 | Completed | Phase 1 | Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer | April 23, 2008 | July 10, 2009 |
| NCT00694252 | Completed | Phase 2 | Lapatinib and Circulating Tumor Cells in Breast Cancer | July 2008 | November 2011 |
| NCT00777101 | Completed | Phase 2 | Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer | February 4, 2009 | June 3, 2018 |
| NCT00790816 | Completed | Phase 1 | Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents | October 2008 | August 19, 2016 |
| NCT00820222 | Completed | Phase 3 | Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer | April 14, 2009 | March 22, 2018 |
| NCT00821054 | Completed | Phase 1 | A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients | March 6, 2009 | March 22, 2011 |
| NCT00826241 | Completed | Phase 2 | Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma | January 2009 | July 31, 2018 |
| NCT00826267 | Completed | Phase 2 | 6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab | January 2009 | |
| NCT00829166 | Completed | Phase 3 | A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer | February 2009 | September 2015 |
| NCT00841828 | Completed | Phase 2 | Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients | February 2009 | December 2013 |
| NCT00849329 | Completed | Phase 1 | A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer | March 10, 2009 | November 24, 2009 |
| NCT00863122 | Completed | Early Phase 1 | Concentration and Activity of Lapatinib in Vestibular Schwannomas | June 2009 | August 2014 |
| NCT00883688 | Completed | Phase 2 | Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma | July 2009 | April 2015 |
| NCT00939523 | Completed | Phase 2 | Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy | July 2009 | December 2018 |
| NCT00952692 | Completed | Phase 1/Phase 2 | Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer | July 2009 | April 2012 |
| NCT00973739 | Completed | Phase 2 | Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors | September 2009 | November 2012 |
| NCT00996762 | Completed | Phase 1 | A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib | November 12, 2009 | September 18, 2012 |
| NCT01013740 | Completed | Phase 2 | Lapatinib in Combination With Vinorelbine | November 25, 2009 | March 1, 2016 |
| NCT01044485 | Completed | Phase 1/Phase 2 | Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer | November 2008 | |
| NCT01068704 | Completed | Phase 2 | Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer | June 2010 | December 2010 |
| NCT01087983 | Completed | Phase 1 | Lapatinib With Sirolimus or Metformin | March 2010 | September 2015 |
| NCT01138384 | Completed | Phase 1/Phase 2 | Study of Foretinib in Combination With Lapatinib in Patients With Metastatic Breast Cancer | October 27, 2010 | February 13, 2015 |
| NCT01160211 | Completed | Phase 3 | A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer | May 5, 2011 | June 6, 2022 |
| NCT01218529 | Completed | Phase 2 | Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors | October 2010 | December 2014 |
| NCT01290354 | Completed | Phase 1 | Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer | September 12, 2011 | March 18, 2013 |
| NCT01300962 | Completed | Phase 1 | Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer | August 2011 | December 31, 2018 |
| NCT01328054 | Completed | Phase 4 | A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval | December 2011 | March 2015 |
| NCT01332396 | Completed | Drug Use Investigation for TYKERB Tablet (All Case Investigation) | June 2009 | March 13, 2017 | |
| NCT01454804 | Completed | Phase 1 | Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors | October 2011 | March 2015 |
| NCT01526369 | Completed | Phase 3 | A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer | February 13, 2012 | February 17, 2023 |
| NCT01636908 | Completed | N/A | Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies. | August 2011 | December 1, 2019 |
| NCT01711658 | Completed | Phase 2 | TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer. | March 15, 2013 | September 21, 2022 |
| NCT01808573 | Completed | Phase 3 | A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting | March 29, 2013 | December 9, 2019 |
| NCT01827163 | Completed | Phase 2 | Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer | April 2013 | January 2019 |
| NCT01875666 | Completed | Early Phase 1 | Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib | August 5, 2013 | December 19, 2016 |
| NCT01973660 | Completed | Phase 2 | PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive Early Breast Cancer | October 2013 | December 2017 |
| NCT02015169 | Completed | Phase 2 | Phase II Study of Neoadjuvant XELOX + Lapatinib in HER2(+) Gastric Cancer Patients With Liver Metastasis | July 9, 2012 | November 17, 2017 |
| NCT02073487 | Completed | Phase 2 | Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel | February 2014 | January 2019 |
| NCT00044343 | Completed | Phase 2 | GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin | September 2002 | October 2003 |
| NCT02338245 | Completed | Phase 2 | Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab | December 29, 2014 | August 25, 2016 |
| NCT02342587 | Completed | Phase 2 | Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer | December 3, 2014 | August 21, 2016 |
| NCT02581124 | Completed | Phase 1 | Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease | October 2015 | April 2016 |
| NCT03084939 | Completed | Phase 3 | Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer | April 24, 2017 | March 14, 2023 |
| NCT00513058 | Completed | Phase 1 | Lapatinib and Vinorelbine in Treating Women With HER2-Overexpressing Locally Advanced or Metastatic Breast Cancer | June 2007 | April 2012 |
| NCT00516672 | Completed | Phase 1 | Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors | September 10, 2007 | October 14, 2015 |
| NCT00524303 | Completed | Phase 2 | Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy. | August 2007 | August 2015 |
| NCT00528281 | Completed | Phase 1 | A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase | September 20, 2007 | May 27, 2009 |
| NCT00536809 | Completed | Phase 1 | Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced Colorectal Cancer | September 26, 2007 | October 31, 2008 |
| NCT00543504 | Completed | Phase 1 | Bevacizumab in Multiple Phase I Combinations | October 10, 2007 | April 29, 2020 |
| NCT00508274 | Terminated | Phase 3 | Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China | July 18, 2007 | July 1, 2020 |
| NCT00272987 | Terminated | Phase 3 | ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib | December 13, 2005 | October 21, 2019 |
| NCT01658358 | Terminated | Phase 1/Phase 2 | ErbB2 Positive Metastatic Breast Cancer | July 2012 | September 2014 |
| NCT00857714 | Terminated | N/A | Lapatinib for Treatment of Ductal Carcinoma In Situ (DCIS) of the Breast | April 2009 | August 2010 |
| NCT01666431 | Terminated | Phase 2 | Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment | June 2012 | November 2013 |
| NCT00239200 | Terminated | Phase 2 | Lapatinib (GW572016) for Metastatic or Recurrent Squamous Cell Carcinoma Esophagus | October 2005 | September 2007 |
| NCT00888810 | Terminated | Phase 2 | Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer | March 2008 | |
| NCT01769508 | Terminated | Phase 2 | Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer | February 2013 | February 2015 |
| NCT00953576 | Terminated | Phase 1/Phase 2 | Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer | September 29, 2009 | April 11, 2013 |
| NCT00963547 | Terminated | Phase 1 | A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015) | September 15, 2009 | December 22, 2011 |
| NCT00968968 | Terminated | Phase 3 | Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone | January 20, 2010 | March 30, 2018 |
| NCT00490061 | Terminated | Phase 2 | Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy | July 2007 | June 2016 |
| NCT01891357 | Terminated | Phase 2 | Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer | September 30, 2013 | November 16, 2016 |
| NCT01934894 | Terminated | Phase 2 | Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases | May 2014 | April 2017 |
| NCT00437073 | Terminated | Phase 2 | Brain Metastases In ErbB2-Positive Breast Cancer | May 2007 | February 2010 |
| NCT01118975 | Terminated | Phase 1/Phase 2 | GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers | March 2010 | October 2012 |
| NCT01145404 | Terminated | Phase 2 | Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer | June 2010 | October 2013 |
| NCT00225758 | Terminated | Phase 2 | Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy | January 2006 | October 2011 |
| NCT01245660 | Terminated | Early Phase 1 | A Phase 0 of Neoadjuvant Lapatinib in Infiltrative Bladder Carcinoma Before Cystectomy | January 2011 | October 2011 |
| NCT01264081 | Terminated | Phase 2 | Lapatinib in Stage IV Melanoma With ERBB4 Mutations | May 20, 2011 | November 22, 2013 |
| NCT00317434 | Terminated | Phase 1 | Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer | November 2005 | April 2007 |
| NCT00479856 | Terminated | Phase 2 | Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer | November 2007 | March 2010 |
| NCT02213042 | Terminated | Phase 2 | Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer | October 24, 2014 | June 4, 2020 |
| NCT00496366 | Terminated | Phase 2 | Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer | July 23, 2007 | March 20, 2017 |
| NCT00754702 | Terminated | Phase 2 | Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer | October 2008 | March 2011 |
| NCT00756470 | Terminated | Phase 2 | Phase II Neoadjuvant in Inflammatory Breast Cancer | October 2008 | October 2013 |
| NCT00759642 | Terminated | Phase 2 | Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy | March 2009 | August 20, 2018 |
| NCT01395537 | Terminated | Phase 1/Phase 2 | Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ) | August 2011 | December 2014 |
| NCT01427322 | Terminated | Early Phase 1 | Randomized RT +/- Lapatinib for Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease | September 2011 | July 2015 |
| NCT00820924 | Terminated | Phase 2 | Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells | June 2008 | July 2011 |
| NCT01477060 | Terminated | Phase 2 | Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With Metastatic Breast Cancer | November 2011 | December 2013 |
| NCT01499160 | Terminated | Phase 2 | Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer | May 2012 | December 2016 |
| NCT02294786 | Terminated | Phase 2 | Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer | December 17, 2014 | October 19, 2017 |
| NCT02230553 | Unknown status | Phase 1/Phase 2 | Lapatinib Plus Trametinib in KRAS Mutant NSCLC | October 2014 | December 2019 |
| NCT01730677 | Unknown status | Phase 2 | Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab | July 2012 | December 2017 |
| NCT00486668 | Unknown status | Phase 3 | A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer | July 2007 | March 2017 |
| NCT02422199 | Unknown status | Phase 1/Phase 2 | A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab | May 2015 | December 2018 |
| NCT02238509 | Unknown status | Phase 2 | Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies | November 2014 | October 2017 |
| NCT02836847 | Unknown status | Phase 2 | Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma | July 2016 | December 2020 |
| NCT04185649 | Unknown status | Phase 3 | The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer | July 1, 2018 | December 31, 2021 |
| NCT02394496 | Unknown status | Phase 3 | Overcoming Endocrine Resistance in Metastatic Breast Cancer | November 2007 | January 2017 |
| NCT03273595 | Unknown status | Phase 2 | Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive Breast Cancer | July 2016 | December 2019 |
| NCT00450203 | Unknown status | Phase 2/Phase 3 | Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric Cancer | October 2007 | December 2017 |
| NCT00513253 | Withdrawn | Phase 1 | A Phase I Study to Test Alternate Oral Formulations vs the Current Tablet Formulation of Lapatinib | April 2008 | May 2008 |
| NCT01137994 | Withdrawn | Phase 2 | A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer | October 2011 | March 2018 |
| NCT00343759 | Withdrawn | Phase 2 | Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy | June 2006 | December 2009 |
| NCT01205217 | Withdrawn | Phase 2 | Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer | December 2010 | December 2010 |
| NCT01005641 | Withdrawn | Phase 2 | ELBA: Exemestane and Lapatinib in Advanced Breast Cancer | December 2009 | March 2012 |
- Trade name (Drug list of Screening Committee of Anticancer Drugs)
- Tykerb
- US Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2007
- Japan Approved Year (20160209) (Drug list of Screening Committee of Anticancer Drugs)
- 2009
- Target (Drug list of Screening Committee of Anticancer Drugs)
- EGFR
- Target (Drug list of Screening Committee of Anticancer Drugs)
- Her2
- Disease name (Drug list of Screening Committee of Anticancer Drugs)
- 乳がん