Lapatinib

Generic Name: Lapatinib

Brand Names: Tykerb, Tyverb

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₂₆ClFN_₄O_₄S

CAS Number: 231277-92-2

Unique Ingredient Identifier: 0VUA21238F

Background: Lapatinib is an anti-cancer drug developed by GlaxoSmithKline (GSK) as a treatment for solid tumours such as breast and lung cancer. It was approved by the FDA on March 13, 2007, for use in patients with advanced metastatic breast cancer in conjunction with the chemotherapy drug capecitabine. Lapatinib is a human epidermal growth factor receptor type 2 (HER2/ERBB2) and epidermal growth factor receptor (HER1/EGFR/ERBB1) tyrosine kinases inhibitor. It binds to the intracellular phosphorylation domain to prevent receptor autophosphorylation upon ligand binding.

Indication: Indicated in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress the human epidermal receptor type 2 (HER2) protein and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.

Associated Conditions: Metastatic Breast Cancer, Refractory, advanced Breast cancer, Refractory, metastatic Breast cancer

Associated Therapies: -

Clinical Trials

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

Phase 2

Completed

Conditions: HER2-positive Gastric Cancer Patients With Liver Metastasis

Interventions: Drug: Lapatinib

First Posted Date: 2013-12-19

Last Posted Date: 2018-01-17

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 32

Registration Number: NCT02015169

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Korea, Republic of

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

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Lapatinib
Drug: Trastuzumab
Drug: Endocrine Therapy
Drug: Paclitaxel

First Posted Date: 2013-10-31

Last Posted Date: 2018-09-19

Lead Sponsor: SOLTI Breast Cancer Research Group

Target Recruit Count: 151

Registration Number: NCT01973660

Locations: 🇪🇸
Hospital Universitario Son Espases, Palma de Mallorca, Islas Baleares, Spain
🇪🇸
Hospital Universitario Virgen de la Arrixaca, El Palmar, Murcia, Spain
🇪🇸
Hospital de Torrevieja, Torrevieja, Alicante, Spain

and more 19 locations

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

Phase 1

Active, not recruiting

Conditions: Unresectable Thyroid Gland Carcinoma
Metastatic Thyroid Gland Carcinoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dabrafenib
Drug: Dabrafenib Mesylate
Procedure: Echocardiography
Drug: Lapatinib
Drug: Lapatinib Ditosylate
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
Procedure: Positron Emission Tomography

First Posted Date: 2013-09-20

Last Posted Date: 2024-10-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 21

Registration Number: NCT01947023

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

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

Phase 2

Terminated

Conditions: Metastatic Breast Cancer With Intracranial Metastases

Interventions: Drug: cabazitaxel
Drug: lapatinib

First Posted Date: 2013-09-04

Last Posted Date: 2017-07-02

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 11

Registration Number: NCT01934894

Locations: 🇺🇸
Florida Cancer Specialists - South, Fort Myers, Florida, United States
🇺🇸
Oncology Hematology Care Inc., Cincinnati, Ohio, United States
🇺🇸
Florida Cancer Specialists-North, Saint Petersburg, Florida, United States

and more 1 locations

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

Phase 2

Terminated

Conditions: Carcinoma, Ductal, Breast

Interventions: Procedure: Biopsy before and after three weeks of study treatment
Drug: paclitaxel
Drug: lapatinib
Drug: trastuzumab

First Posted Date: 2013-07-03

Last Posted Date: 2019-09-17

Lead Sponsor: West German Study Group

Target Recruit Count: 64

Registration Number: NCT01891357

Locations: 🇩🇪
Klinikum Esslingen, Esslingen, Baden-Württemberg, Germany
🇩🇪
Niels-Stensen-Kliniken, Georgsmarienhütte, Niedersachsen, Germany
🇩🇪
SLK Kliniken, Heilbronn, Baden-Württemberg, Germany

and more 7 locations

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

Early Phase 1

Completed

Conditions: Breast Neoplasms

Interventions: Drug: pertuzumab
Drug: Trastuzumab
Drug: lapatinib

First Posted Date: 2013-06-12

Last Posted Date: 2020-09-04

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 26

Registration Number: NCT01875666

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
MD Anderson, Houston, Texas, United States

and more 2 locations

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

Phase 2

Completed

Conditions: HER2-Positive Early Stage Breast Cancer

Interventions: Drug: Paclitaxel
Drug: Trastuzumab
Drug: Lapatinib
Drug: Pegfilgrastim

First Posted Date: 2013-04-09

Last Posted Date: 2019-12-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 20

Registration Number: NCT01827163

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan-Kettering Cancer Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 1 locations

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

Phase 3

Completed

Conditions: HER2+ Metastatic Breast Cancer (MBC)

Interventions: Drug: neratinib
Drug: capecitabine
Drug: lapatinib

First Posted Date: 2013-03-11

Last Posted Date: 2021-06-11

Lead Sponsor: Puma Biotechnology, Inc.

Target Recruit Count: 621

Registration Number: NCT01808573

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States
🇺🇸
University of California San Diego Medical Center - Hillcrest, San Diego, California, United States
🇺🇸
Sharp Memorial Hospital, San Diego, California, United States

and more 233 locations

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

Phase 2

Terminated

Conditions: HER2 Positive Esophagogastric Cancer

Interventions: Drug: 5-Fluorouracil
Drug: Oxaliplatin
Drug: Lapatinib
Radiation: Radiation Therapy

First Posted Date: 2013-01-16

Last Posted Date: 2016-06-13

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 12

Registration Number: NCT01769508

Locations: 🇺🇸
Tennessee Oncology, Nashville, Tennessee, United States
🇺🇸
Florida Cancer Specialists-North, St. Petersburg, Florida, United States
🇺🇸
Chattanooga Oncology and Hematology Associates, Chattanooga, Tennessee, United States

and more 6 locations

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

Phase 2

Conditions: Metastatic Breast Cancer

Interventions: Drug: Lapatinib
Drug: Vinorelbine

First Posted Date: 2012-11-21

Last Posted Date: 2014-03-12

Lead Sponsor: National Cancer Center, Korea

Target Recruit Count: 150

Registration Number: NCT01730677

Locations: 🇰🇷
National Cancer Center, Goyang-si, Gyeonggi-do, Korea, Republic of

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