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

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

Phase 2

Terminated

Conditions: Metastatic Breast Cancer

Interventions: Drug: Metformin
Drug: Lapatinib

First Posted Date: 2011-11-22

Last Posted Date: 2014-02-20

Lead Sponsor: Fondazione Michelangelo

Target Recruit Count: 32

Registration Number: NCT01477060

Locations: 🇮🇹
Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni, Bergamo, BG, Italy
🇮🇹
Fondazione Poliambulanza, Brescia, BS, Italy
🇮🇹
Azienda Ospedaliera San Gerardo, Monza, MB, Italy

and more 8 locations

Pazopanib, Lapatinib or Trastuzumab in Subjects With Solid Tumors

Phase 1

Completed

Conditions: Advanced Cancers

Interventions: Drug: Pazopanib
Drug: Trastuzumab (Herceptin®)
Drug: Lapatinib

First Posted Date: 2011-10-19

Last Posted Date: 2016-04-13

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 43

Registration Number: NCT01454804

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Entinostat, Lapatinib Ditosylate and Trastuzumab in Treating Patients With Locally Recurrent or Distant Relapsed Metastatic Breast Cancer Previously Treated With Trastuzumab Only

Phase 1

Completed

Conditions: Recurrent Breast Carcinoma
HER2/Neu Positive
Stage IV Breast Cancer AJCC v6 and v7
Invasive Breast Carcinoma

Interventions: Drug: Entinostat
Other: Laboratory Biomarker Analysis
Drug: Lapatinib Ditosylate
Biological: Trastuzumab

First Posted Date: 2011-09-14

Last Posted Date: 2019-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 37

Registration Number: NCT01434303

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

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

Early Phase 1

Terminated

Conditions: Epithelial Cancer

Interventions: Radiation: Radiation therapy
Drug: Lapatinib

First Posted Date: 2011-09-01

Last Posted Date: 2015-07-08

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 6

Registration Number: NCT01427322

Locations: 🇺🇸
Hunter Holmes McGuire VA Medical Center, Richmond, Virginia, United States
🇺🇸
Massey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, United States

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

Phase 1

Terminated

Conditions: Adenocarcinoma of the Esophagus
Adenocarcinoma of the Gastroesophageal Junction

Interventions: Drug: Carboplatin AUC
Drug: Paclitaxel
Drug: lapatinib

First Posted Date: 2011-07-15

Last Posted Date: 2019-03-19

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 13

Registration Number: NCT01395537

Locations: 🇺🇸
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Completed

Conditions: Cancer

Interventions: Drug: Lapatinib

First Posted Date: 2011-04-11

Last Posted Date: 2017-04-26

Lead Sponsor: Novartis

Target Recruit Count: 4054

Registration Number: NCT01332396

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

Phase 4

Completed

Conditions: Cancer

Interventions: Drug: lapatinib
Drug: placebo matching lapatinib

First Posted Date: 2011-04-04

Last Posted Date: 2016-06-08

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 58

Registration Number: NCT01328054

Locations: 🇺🇸
GSK Investigational Site, Salt Lake City, Utah, United States

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

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell Lung
Carcinoma, Thymic

Interventions: Drug: Erlotinib
Drug: AZD6244
Drug: MK-2206
Drug: Lapatinib
Drug: Sunitinib
Procedure: Molecular Profiling

First Posted Date: 2011-03-01

Last Posted Date: 2024-10-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 647

Registration Number: NCT01306045

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

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

Phase 1

Completed

Conditions: Metastatic Breast Cancer

Interventions: Drug: BMK120
Drug: Capecitabine
Drug: BYL719
Drug: Trastuzumab
Drug: Lapatinib

First Posted Date: 2011-02-23

Last Posted Date: 2023-12-04

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 47

Registration Number: NCT01300962

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸
Duke Comprehensive Cancer Center, Durham, North Carolina, United States

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

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: Lapatinib
Drug: [11C] lapatinib

First Posted Date: 2011-02-07

Last Posted Date: 2017-11-13

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 10

Registration Number: NCT01290354

Locations: 🇬🇧
GSK Investigational Site, London, United Kingdom

Drug Development Updates

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