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

Bevacizumab and Lapatinib in Children With Recurrent or Refractory Ependymoma

Phase 2

Completed

Conditions: Brain Cancer
Pediatric Cancers

Interventions: Drug: Bevacizumab
Drug: Lapatinib

First Posted Date: 2009-04-20

Last Posted Date: 2020-08-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT00883688

Locations: 🇺🇸
Children's Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
🇺🇸
Stanford University Medical Center, Stanford, California, United States

and more 3 locations

Concentration and Activity of Lapatinib in Vestibular Schwannomas

Early Phase 1

Completed

Conditions: NF2
Acoustic Neuroma
Neurofibromatosis 2
Auditory Tumor
Vestibular Schwannoma

Interventions: Drug: lapatinib

First Posted Date: 2009-03-17

Last Posted Date: 2021-01-12

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 26

Registration Number: NCT00863122

Locations: 🇺🇸
House Reserach Institute, Los Angeles, California, United States
🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States
🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

and more 4 locations

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

Not Applicable

Terminated

Conditions: Ductal Carcinoma in Situ

First Posted Date: 2009-03-09

Last Posted Date: 2015-07-08

Lead Sponsor: Indiana University

Target Recruit Count: 1

Registration Number: NCT00857714

Locations: 🇺🇸
Indiana University, Indianapolis, Indiana, United States

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

Phase 1

Completed

Conditions: Neoplasms, Breast

Interventions: Drug: lapatinib
Drug: lapatinib plus esomeprazole

First Posted Date: 2009-02-23

Last Posted Date: 2017-11-14

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 12

Registration Number: NCT00849329

Locations: 🇪🇸
GSK Investigational Site, Hospitalet de Llobregat (Barcelona), Spain

Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Lapatinib
Drug: Trastuzumab

First Posted Date: 2009-02-11

Last Posted Date: 2023-03-31

Lead Sponsor: Spanish Breast Cancer Research Group

Target Recruit Count: 102

Registration Number: NCT00841828

Locations: 🇪🇸
Hospital General de Granollers, Granollers, Barcelona, Spain
🇪🇸
Onkologikoa, Donostia-San Sebastián, Guipuzcoa, Spain
🇪🇸
Hospital Central de Asturias, Oviedo, Asturias, Spain

and more 23 locations

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

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Drug: Trastuzumab emtansine
Drug: Lapatinib
Drug: Capecitabine

First Posted Date: 2009-01-26

Last Posted Date: 2016-10-31

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 991

Registration Number: NCT00829166

Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma

Phase 2

Completed

Conditions: Brain Tumors
Spinal Cord Tumors

Interventions: Drug: Temozolomide
Drug: Lapatinib

First Posted Date: 2009-01-22

Last Posted Date: 2019-03-22

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Target Recruit Count: 58

Registration Number: NCT00826241

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 3 locations

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

Phase 2

Completed

Conditions: Breast Neoplasms

Interventions: Drug: BIBW 2992
Drug: lapatinib
Drug: trastuzumab

First Posted Date: 2009-01-22

Last Posted Date: 2013-12-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 29

Registration Number: NCT00826267

Locations: 🇺🇸
1200.44.01001 Boehringer Ingelheim Investigational Site, Houston, Texas, United States
🇧🇷
1200.44.12005 Boehringer Ingelheim Investigational Site, Ijui, Brazil
🇧🇷
1200.44.12007 Boehringer Ingelheim Investigational Site, Natal, Brazil

and more 14 locations