Tykerb

(lapatinib)

Phase 3Small molecule

Lapatinib is used to treat certain types of breast cancer by blocking proteins that help cancer cells grow and survive.[1] Tykerb is currently being investigated across 7 indications[3], with its most advanced program in Phase 3.[1]

Tykerb is one of 130 small molecule programs targeting Breast Neoplasm. It is currently in Phase 3.

Indications

158

Total Trials

Active Trials

129

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast NeoplasmUnknown

Breast Ductal Carcinoma in SituActive, not recruiting

Thyroid CancerActive, not recruiting

Malignant Solid NeoplasmsRecruiting

Breast NeoplasmsActive, not recruiting

Endocrine TherapyCompleted

Advanced Soft-Tissue SarcomaActive, not recruiting

Breast NeoplasmPreclinical

Unknown

Breast Ductal Carcinoma in SituPreclinical

Active, not recruiting

Thyroid CancerPhase 1

Active, not recruiting

Malignant Solid NeoplasmsPhase 2

Recruiting

Breast NeoplasmsPhase 2

Active, not recruiting

Endocrine TherapyPhase 2

Completed

Advanced Soft-Tissue SarcomaPhase 3

Active, not recruiting

Competition

Competitive Landscape

71 competitors in Breast Neoplasm

#DrugCompanyPhaseTrials

Taxol

Teva

Approved

1 2

Kisqali

Novartis

Approved

1 3

Verzenio

Eli Lilly

Approved

1 4

Nolvadex

AstraZeneca

Approved

1 5

Tykerb

Zofran

Fotivda

Venclexta

Zometa

Tukysa

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 2Active, not recruiting

Breast Neoplasms

NCT01273610

Q4 2028

Phase 2Recruiting

Malignant Solid Neoplasms

NCT02029001

Clinical

Trials by Indication[1]

Breast Cancer80 trials

Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer

Terminated· Novartis logo

Novartis·Phase 2·NCT02213042·42 enrolled

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

Unknown status·JJiangsu HengRui Medicine Co., Ltd.·Phase 1/2·NCT02422199·128 enrolled

A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

Completed· Roche logo

Roche·Phase 3·NCT00829166·991 enrolled

Show 77 more trials

Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01068704·4 enrolled

The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer

Unknown status·BBio-Thera Solutions·Phase 3·NCT04185649·410 enrolled

Study of Foretinib in Combination With Lapatinib in Patients With Metastatic Breast Cancer

Completed·NNCIC Clinical Trials Group·Phase 1/2·NCT01138384·19 enrolled

ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Withdrawn·NNational Cancer Institute, Naples·Phase 2·NCT01005641

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

Completed· GSK logo

GSK·Phase 1·NCT00359190·28 enrolled

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

Completed·PPuma Biotechnology, Inc.·Phase 3·NCT01808573·621 enrolled

Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer

Completed·NNancy Lin, MD·Phase 1·NCT00470847·35 enrolled

Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00089999·138 enrolled

Letrozole and Lapatinib Followed by Everolimus in Women With Advanced Breast Cancer

Terminated·UUniversity of Maryland, Baltimore·Phase 2·NCT01499160·7 enrolled

Lapatinib and Bevacizumab for Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT00444535·52 enrolled

Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

Completed·NNancy Lin, MD·Phase 2·NCT00470704·87 enrolled

Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China

Terminated· Novartis logo

Novartis·Phase 3·NCT00508274·52 enrolled

A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer

Withdrawn· GSK logo

GSK·Phase 2·NCT01137994

Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer

Completed·MMichael Morse, MD·Phase 1/2·NCT00952692·12 enrolled

Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

Completed·CCentre Georges Francois Leclerc·Phase 1/2·NCT01044485·17 enrolled

T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer

Completed·JJenny C. Chang, MD·Phase 1·NCT02073916·24 enrolled

PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive Early Breast Cancer

Completed·SSOLTI Breast Cancer Research Group·Phase 2·NCT01973660·151 enrolled

Overcoming Endocrine Resistance in Metastatic Breast Cancer

Unknown status·CConsorzio Oncotech·Phase 3·NCT02394496·396 enrolled

Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab

Unknown status·NNational Cancer Center, Korea·Phase 2·NCT01730677·150 enrolled

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Completed·PPuma Biotechnology, Inc.·Phase 2·NCT00777101·233 enrolled

Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy

Terminated·GGary Schwartz·Phase 2·NCT00225758·27 enrolled

Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer

Terminated· GSK logo

GSK·Phase 2·NCT00479856·9 enrolled

Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT01875666·26 enrolled

Lapatinib and Vinorelbine in Treating Women With HER2-Overexpressing Locally Advanced or Metastatic Breast Cancer

Completed·UUNICANCER·Phase 1·NCT00513058·33 enrolled

Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With Metastatic Breast Cancer

Terminated·FFondazione Michelangelo·Phase 2·NCT01477060·32 enrolled

A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer

Completed·CCancer Trials Ireland·Phase 3·NCT01526369·75 enrolled

6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 2·NCT00826267·29 enrolled

Exploratory Lapatinib (Positron Emission Tomography) PET Study in Subjects With Breast Cancer

Completed· GSK logo

GSK·Phase 1·NCT01290354·10 enrolled

Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer

Completed· Roche logo

Roche·Phase 3·NCT03084939·351 enrolled

GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers

Terminated·UUniversity of Maryland, Baltimore·Phase 1/2·NCT01118975·12 enrolled

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

Unknown status·RRemeGen Co., Ltd.·Phase 2/3·NCT03500380·301 enrolled

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

Terminated· Novartis logo

Novartis·Phase 2·NCT02294786·62 enrolled

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

Completed· Novartis logo

Novartis·Phase 3·NCT01160211·369 enrolled

ErbB2 Positive Metastatic Breast Cancer

Terminated·—·Phase 1/2·NCT01658358·15 enrolled

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT03523585·608 enrolled

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

Unknown status·NNSABP Foundation Inc·Phase 3·NCT00486668·529 enrolled

Combination Of Lapatinib With Carboplatin, Paclitaxel, and With or Without Trastuzumab In Metastatic Breast Cancer.

Completed· Novartis logo

Novartis·Phase 1·NCT00367471·31 enrolled

Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer

Terminated·—·Phase 2·NCT00754702·16 enrolled

Phase II Trial to Validate Markers for a Response Evaluation of a Combined Therapy in Patients With HER2+ Breast Cancer

Terminated·WWest German Study Group·Phase 2·NCT01891357·64 enrolled

Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00429299·121 enrolled

Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT01300962·47 enrolled

Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

Completed· GSK logo

GSK·Phase 3·NCT00320385·296 enrolled

Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2

Completed· Novartis logo

Novartis·Phase 3·NCT00281658·444 enrolled

Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients

Completed·SSwedish Medical Center·Phase 1/2·NCT00316407·30 enrolled

Primary Chemotherapy in Patients With HER2-positive Early Breast Cancer

Completed·PProf Dirk Elling·Phase 1/2·NCT01172223·81 enrolled

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00347919·189 enrolled

Lapatinib Combined With Paclitaxel For Patients With First-Line ErbB2-Amplified Metastatic Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00356811·57 enrolled

Capecitabine (XELODA) With Or Without Lapatinib (GW572016) For Women With Refractory Advanced or Metastatic Breast Cancer

Completed· GSK logo

GSK·Phase 3·NCT00078572·408 enrolled

Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases

Terminated·SSCRI Development Innovations, LLC·Phase 2·NCT01934894·11 enrolled

Phase II Neoadjuvant in Inflammatory Breast Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00756470·15 enrolled

Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive Breast Cancer

Unknown status·XXijing Hospital·Phase 2·NCT03273595·100 enrolled

A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients

Completed· GSK logo

GSK·Phase 1·NCT00821054·24 enrolled

A Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects With Metastatic ErbB2 Positive Breast Cancer

Completed· GSK logo

GSK·Phase 1·NCT00849329·12 enrolled

Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer

Completed· GSK logo

GSK·Phase 3·NCT00374322·3,166 enrolled

Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells

Terminated· GSK logo

GSK·Phase 2·NCT00820924·23 enrolled

Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.

Completed· GSK logo

GSK·Phase 2·NCT00524303·100 enrolled

Lapatinib and Circulating Tumor Cells in Breast Cancer

Completed·—·Phase 2·NCT00694252·20 enrolled

Short-term Presurgical Study to Assess Molecular Predictors of Lapatinib's Effects in Primary Breast Cancer

Completed·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT00299286·121 enrolled

Neoadjuvant GW572016 to Treat Breast Cancer

Completed·BBaylor Breast Care Center·Phase 2·NCT00206427·49 enrolled

Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer

Withdrawn· GSK logo

GSK·Phase 2·NCT01205217

ErbB2 Over-expressing Metastatic Breast Cancer Study Using Paclitaxel, Trastuzumab, and Lapatinib

Terminated· Novartis logo

Novartis·Phase 3·NCT00272987·63 enrolled

Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01827163·20 enrolled

GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00320411·62 enrolled

Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00073528·1,286 enrolled

Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer

Terminated·RRutgers, The State University of New Jersey·Phase 2·NCT00496366·11 enrolled

LBH589 in Combination With Capecitabine Plus/Minus (±) Lapatinib in Breast Cancer Patients

Completed·SSCRI Development Innovations, LLC·Phase 1·NCT00632489·20 enrolled

Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00477464·51 enrolled

Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00111787·49 enrolled

Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy

Terminated·UUniversity of Kansas Medical Center·Phase 2·NCT00759642·33 enrolled

Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00558103·163 enrolled

Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00422903·92 enrolled

Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Completed· Novartis logo

Novartis·Phase 2·NCT00263588·242 enrolled

Study To Examine The Effects Of Lapatinib On The Pharmacokinetics Of Digoxin In Subjects w/ ErbB2 Positive Breast Cancer

Completed· GSK logo

GSK·Phase 1·NCT00650910·17 enrolled

Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer

Completed·GGeorge Albert Fisher·Phase 2·NCT00404066·21 enrolled

Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer

Completed· GSK logo

GSK·Phase 2·NCT00105950·126 enrolled

Brain Metastases In ErbB2-Positive Breast Cancer

Terminated· GSK logo

GSK·Phase 2·NCT00437073·22 enrolled

Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 3·NCT00820222·540 enrolled

Apatinib7 trials

Lapatinib Plus Trametinib in KRAS Mutant NSCLC

Completed·TThe Netherlands Cancer Institute·Phase 1/2·NCT02230553·35 enrolled

A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib

Completed· GSK logo

GSK·Phase 1·NCT00996762·158 enrolled

A Phase I Study to Test Alternate Oral Formulations vs the Current Tablet Formulation of Lapatinib

Withdrawn· GSK logo

GSK·Phase 1·NCT00513253

Show 4 more trials

Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone

Terminated· Novartis logo

Novartis·Phase 3·NCT00968968·37 enrolled

The Myocet/Lapatinib Study. ICORG 10-03, V5

Terminated·CCancer Trials Ireland·Phase 1/2·NCT01495884·11 enrolled

A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval

Completed· GSK logo

GSK·Phase 4·NCT01328054·58 enrolled

Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients

Completed· GSK logo

GSK·Phase 1·NCT00158782·75 enrolled

Gastric Cancer5 trials

Phase II Study of Neoadjuvant XELOX + Lapatinib in HER2(+) Gastric Cancer Patients With Liver Metastasis

Completed·SSamsung Medical Center·Phase 2·NCT02015169·32 enrolled

Study of 5-FU, Oxaliplatin, & Lapatinib Combined With Radiation Therapy to Treat HER2 Positive Esophagogastric Cancer

Terminated·SSCRI Development Innovations, LLC·Phase 2·NCT01769508·12 enrolled

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

Completed· Novartis logo

Novartis·Phase 3·NCT00680901·545 enrolled

Show 2 more trials

Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

Completed· GSK logo

GSK·Phase 3·NCT00486954·273 enrolled

Chemotherapy With or Without Bevacizumab or Lapatinib to Treat Operable Oesophagogastric Cancer

Unknown status·PProfessor David Cunningham·Phase 2/3·NCT00450203·1,103 enrolled

Head and Neck Cancer4 trials

TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.

Completed· Radiation Therapy Oncology Group logo

Radiation Therapy Oncology Group·Phase 2·NCT01711658·142 enrolled

Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy

Terminated·QQuynh-Thu Le·Phase 2·NCT00490061·17 enrolled

Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer

Completed· GSK logo

GSK·Phase 2·NCT00387127·67 enrolled

Show 1 more trial

Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery

Completed· GSK logo

GSK·Phase 3·NCT00424255·688 enrolled

Squamous Cell Carcinoma2 trials

Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment

Terminated·UUniversity of Zurich·Phase 2·NCT01666431·10 enrolled

Lapatinib (GW572016) for Metastatic or Recurrent Squamous Cell Carcinoma Esophagus

Terminated·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT00239200·29 enrolled

54 more indications

Vinorelbine2 trials

Lapatinib in Combination With Vinorelbine

Completed· GSK logo

GSK·Phase 2·NCT01128543·29 enrolled

Lapatinib in Combination With Vinorelbine

Completed· Novartis logo

Novartis·Phase 2·NCT01013740·112 enrolled

Endocrine Therapy2 trials

Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy

Active, not recruiting·BBaylor Breast Care Center·Phase 2·NCT00999804·128 enrolled

Lapatinib and Trastuzumab With or Without Endocrine Therapy

Completed·BBaylor Breast Care Center·Phase 2·NCT00548184·65 enrolled

Colorectal Cancer2 trials

GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

Completed· GSK logo

GSK·Phase 2·NCT00044343·80 enrolled

Phase I/II Study of Lapatinib in Combination With Oxaliplatin and Capecitabine in Subjects With Advanced Colorectal Cancer

Completed· GSK logo

GSK·Phase 1·NCT00536809·12 enrolled

Solid Tumors2 trials

A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1·NCT00963547·33 enrolled

Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01454804·43 enrolled

Neoadjuvant2 trials

Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel

Completed·TThe Methodist Hospital Research Institute·Phase 2·NCT02073487·32 enrolled

Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study

Completed· Novartis logo

Novartis·Phase 3·NCT00553358·455 enrolled

Ependymoma2 trials

Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 2·NCT00826241·58 enrolled

Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00883688·24 enrolled

Patients With Solid Tumors1 trial

Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors

Completed· GSK logo

GSK·Phase 1·NCT00516672·30 enrolled

Non-Small Cell Lung Cancer1 trial

Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01306045·647 enrolled

Chemotherapy1 trial

Phase I/II Study of Lapatinib in Combination With Paclitaxel as 1L Chemotherapy for ErbB2-positive MBC

Completed· GSK logo

GSK·Phase 2·NCT01138046·12 enrolled

Advanced Cancer1 trial

Safety and Clinical Activity of Lapatinib in Patients With HER2-positive Refractory Advanced Cancer

Completed·SSamsung Medical Center·Phase 2·NCT02342587·7 enrolled

Targeted Therapy1 trial

Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy

Withdrawn·UUniversity of Pennsylvania·Phase 2·NCT00343759

Neurofibromatosis1 trial

Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

Completed·NNYU Langone Health·Phase 2·NCT00973739·21 enrolled

Drug1 trial

Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Completed· Novartis logo

Novartis··NCT01332396·4,054 enrolled

Bladder Carcinoma1 trial

A Phase 0 of Neoadjuvant Lapatinib in Infiltrative Bladder Carcinoma Before Cystectomy

Terminated·UUniversity Hospital, Bordeaux·Phase 1·NCT01245660·3 enrolled

Intravenous1 trial

To Examine The Effects Of Lapatinib On Orally And Intravenously Administered Midazolam In Cancer Patients

Completed· GSK logo

GSK·Phase 1·NCT00258050·24 enrolled

Advanced Solid Tumor1 trial

Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00495872·204 enrolled

Peritoneal Cancer1 trial

Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer

Terminated·CCentre Francois Baclesse·Phase 2·NCT00888810·39 enrolled

Monotherapy1 trial

Continuation Study of Lapatinib Monotherapy or Lapatinib in Combination With Other Anti-cancer Agents

Completed· Novartis logo

Novartis·Phase 1·NCT00790816·500 enrolled

Ductal Carcinoma in Situ1 trial

Lapatinib for Treatment of Ductal Carcinoma In Situ (DCIS) of the Breast

Terminated·IIndiana University·N/A·NCT00857714·1 enrolled

Melanoma1 trial

Lapatinib in Stage IV Melanoma With ERBB4 Mutations

Terminated·NNational Cancer Institute (NCI)·Phase 2·NCT01264081·34 enrolled

Refractory1 trial

Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies

Unknown status·CConsorzio Oncotech·Phase 2·NCT02238509·154 enrolled

Carboplatin1 trial

Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)

Completed· GSK logo

GSK·Phase 1·NCT00388076·86 enrolled

Thyroid Cancer1 trial

Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01947023·21 enrolled

Advanced Solid Malignancies1 trial

Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.

Completed·AAmsterdam UMC, location VUmc·N/A·NCT01636908·43 enrolled

Prostate Cancer1 trial

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

Terminated·—·Phase 1/2·NCT00953576·11 enrolled

Small Cell Lung Cancer1 trial

A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase

Completed· GSK logo

GSK·Phase 1·NCT00528281·18 enrolled

Gastroesophageal Junction1 trial

Lapatinib With Carboplatin and Paclitaxel in Esophagus and Gastroesophageal Junction (GEJ)

Terminated·—·Phase 1/2·NCT01395537·13 enrolled

Capecitabine1 trial

Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab

Completed·AASLAN Pharmaceuticals·Phase 2·NCT02338245·200 enrolled

Patients With Advanced Solid Tumors1 trial

Lapatinib and Paclitaxel in Treating Patients With Advanced Solid Tumors

Completed·UUniversity of California, San Francisco·Phase 1·NCT00313599·28 enrolled

Cervical Cancer1 trial

Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer

Completed· GSK logo

GSK·Phase 2·NCT00430781·228 enrolled

Locally Advanced Head and Neck Cancer1 trial

A Study Of Lapatinib Versus Placebo Followed By Chemoradiation In Patients With Locally Advanced Head And Neck Cancer

Completed· GSK logo

GSK·Phase 2·NCT00371566·107 enrolled

Adenocarcinoma1 trial

Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

Completed· GSK logo

GSK·Phase 2·NCT00259987·24 enrolled

Neoadjuvant Treatment1 trial

Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

Completed·SSpanish Breast Cancer Research Group·Phase 2·NCT00841828·102 enrolled

Malignant Glioma1 trial

Pazopanib In Combination With Lapatinib In Adult Patients With Relapsed Malignant Glioma

Completed· GSK logo

GSK·Phase 2·NCT00350727·75 enrolled

Esophageal Cancer1 trial

Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer

Terminated·NNational Center for Tumor Diseases, Heidelberg·Phase 2·NCT01145404·76 enrolled

Pituitary Tumor1 trial

Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy

Completed·—·Phase 2·NCT00939523·9 enrolled

Brain Metastases1 trial

Lapatinib and WBRT for Patients With Brain Metastases From Lung or Breast Tumors

Completed·HHellenic Cooperative Oncology Group·Phase 2·NCT01218529·82 enrolled

Surgery1 trial

Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT01612351·40 enrolled

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Vestibular schwannoma1 trial

Concentration and Activity of Lapatinib in Vestibular Schwannomas

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00863122·26 enrolled

Treatment1 trial

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

Completed· Novartis logo

Novartis·Phase 3·NCT00490139·8,381 enrolled

Colorectal Adenocarcinoma1 trial

Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT00574171·29 enrolled

Advanced Soft-tissue Sarcoma1 trial

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT03784014·603 enrolled

Bevacizumab1 trial

Bevacizumab in Multiple Phase I Combinations

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00543504·343 enrolled

End-Stage Renal Disease1 trial

Study to Evaluate Effect of Lapatinib on Pharmacokinetics of JTZ-951 in Subjects With End-stage Renal Disease

Completed·AAkros Pharma Inc.·Phase 1·NCT02581124·10 enrolled

Metformin1 trial

Lapatinib With Sirolimus or Metformin

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01087983·111 enrolled

Glioma1 trial

Lapatinib Ditosylate Before Surgery in Treating Patients With Recurrent High-Grade Glioma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02101905·29 enrolled

Advanced Solid Tumor Cancer1 trial

Randomized RT +/- Lapatinib for Advanced Solid Tumor Cancer Patients Receiving Radiation Therapy for Metastatic Disease

Terminated·VVirginia Commonwealth University·Phase 1·NCT01427322·6 enrolled

Ovarian Cancer1 trial

Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

Terminated·UUniversity of Alabama at Birmingham·Phase 1·NCT00317434·12 enrolled

Gallbladder Carcinoma1 trial

Molecularly Target Therapy With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

Unknown status·SShanghai Jiao Tong University School of Medicine·Phase 2·NCT02836847·152 enrolled

Primary Peritoneal Cancer1 trial

Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin

Completed·MMayo Clinic·Phase 2·NCT00436644·18 enrolled

Malignant Solid Neoplasms1 trial

A Two-period, Multicenter, Randomized, Open-label, Phase II Study Evaluating the Clinical Benefit of a Maintenance Treatment Targeting Tumor Molecular Alterations in Patients With Progressive Locally-advanced or Metastatic Solid Tumors

Recruiting·CCentre Leon Berard·Phase 2·NCT02029001·900 enrolled

Breast Neoplasms1 trial

Tolerability of the Combination of Lapatinib and Trastuzumab in Adults Age 60 or Older With HER2 Positive Locally Advanced or Metastatic Breast Cancer

Active, not recruiting·CCity of Hope Medical Center·Phase 2·NCT01273610·40 enrolled

Unspecified1 trial

Effects Of GW572016 In Combination With Docetaxel (TAXOTERE)

Completed· GSK logo

GSK·Phase 1·NCT00148902·52 enrolled

Sources

References

[1]
ClinicalTrials.gov — 158 trial records for lapatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — lapatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for lapatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — GSK company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Epidermal Growth Factor Receptor Erbb1 Inhibitor; Receptor Protein-Tyrosine Kinase Erbb-2 Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: GSK

Tykerb

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2028

Trials by Indication[1]

Breast Cancer80 trials

Apatinib7 trials

Gastric Cancer5 trials

Head and Neck Cancer4 trials

Squamous Cell Carcinoma2 trials

Vinorelbine2 trials

Endocrine Therapy2 trials

Colorectal Cancer2 trials

Solid Tumors2 trials

Neoadjuvant2 trials

Ependymoma2 trials

Patients With Solid Tumors1 trial

Non-Small Cell Lung Cancer1 trial

Chemotherapy1 trial

Advanced Cancer1 trial

Targeted Therapy1 trial

Neurofibromatosis1 trial

Drug1 trial

Bladder Carcinoma1 trial

Intravenous1 trial

Advanced Solid Tumor1 trial

Peritoneal Cancer1 trial

Monotherapy1 trial

Ductal Carcinoma in Situ1 trial

Melanoma1 trial

Refractory1 trial

Carboplatin1 trial

Thyroid Cancer1 trial

Advanced Solid Malignancies1 trial

Prostate Cancer1 trial

Small Cell Lung Cancer1 trial

Gastroesophageal Junction1 trial

Capecitabine1 trial

Patients With Advanced Solid Tumors1 trial

Cervical Cancer1 trial

Locally Advanced Head and Neck Cancer1 trial

Adenocarcinoma1 trial

Neoadjuvant Treatment1 trial

Malignant Glioma1 trial

Esophageal Cancer1 trial

Pituitary Tumor1 trial

Brain Metastases1 trial

Surgery1 trial

Immunotherapy1 trial

Vestibular schwannoma1 trial

Treatment1 trial

Colorectal Adenocarcinoma1 trial

Advanced Soft-tissue Sarcoma1 trial

Bevacizumab1 trial

End-Stage Renal Disease1 trial

Metformin1 trial

Glioma1 trial

Advanced Solid Tumor Cancer1 trial

Ovarian Cancer1 trial

Gallbladder Carcinoma1 trial

Primary Peritoneal Cancer1 trial

Malignant Solid Neoplasms1 trial

Breast Neoplasms1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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