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

Clinical Trials

Dose Escalation of Lapatinib With Paclitaxel in Ovarian Cancer

Phase 1

Completed

Conditions: Ovarian Cancer

Interventions: Drug: Lapatinib and Paclitaxel

First Posted Date: 2020-10-29

Last Posted Date: 2025-03-11

Lead Sponsor: Frederick R. Ueland, M.D.

Target Recruit Count: 15

Registration Number: NCT04608409

Locations: 🇺🇸
Markey Cancer Center, Lexington, Kentucky, United States

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

Phase 2

Active, not recruiting

Conditions: Other Cancer
Breast Cancer
Gastrointestinal Cancer
Non Small Cell Lung Cancer

First Posted Date: 2020-10-19

Last Posted Date: 2023-10-03

Lead Sponsor: Fondazione per la Medicina Personalizzata

Target Recruit Count: 400

Registration Number: NCT04591431

Locations: 🇮🇹
I.R.S.T. Srl Irccs, Meldola, Italy
🇮🇹
Ospedale Classificato Sacro Cuore - Don Calabria, Negrar, Italy
🇮🇹
I.R.C.C.S. Istituto Oncologico Veneto, Padova, Italy

and more 34 locations

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

Phase 3

Conditions: HER2-positive Advanced Breast Cancer

Interventions: Biological: BAT8001 for injection
Drug: Lapatinib
Drug: Capecitabine

First Posted Date: 2019-12-04

Last Posted Date: 2019-12-04

Lead Sponsor: Bio-Thera Solutions

Target Recruit Count: 410

Registration Number: NCT04185649

Locations: 🇨🇳
Beijing Shijitan Hospital, Beijing, Beijing, China
🇨🇳
The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
🇨🇳
Anhui Provincial Hospital, Hefei, Anhui, China

and more 48 locations

Molecular Profiling of Advanced Soft-tissue Sarcomas

Phase 3

Active, not recruiting

Conditions: Soft Tissue Sarcoma

Interventions: Other: Next Generation sequencing exome
Drug: Nilotinib
Drug: Ceritinib
Drug: Capmatinib
Drug: Lapatinib
Drug: Trametinib
Combination Product: Trametinib and Dabrafenib
Combination Product: Olaparib and Durvalumab
Drug: Palbociclib
Drug: Glasdegib
Drug: TAS-120

First Posted Date: 2018-12-21

Last Posted Date: 2025-01-28

Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Target Recruit Count: 603

Registration Number: NCT03784014

Locations: 🇫🇷
Centre Oscar Lambret, Lille, France
🇫🇷
IUCT Oncopôle, Toulouse, France
🇫🇷
Institut de Cancérologie de Montpellier, Montpellier, France

and more 16 locations

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

Phase 3

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Trastuzumab deruxtecan
Drug: Capecitabine
Drug: Trastuzumab
Drug: Lapatinib

First Posted Date: 2018-05-14

Last Posted Date: 2024-11-05

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 608

Registration Number: NCT03523585

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
The Methodist Hospital Research Institute, Houston, Texas, United States
🇧🇪
Az Groeninge, Kortrijk, Belgium

and more 221 locations

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

Phase 2

Active, not recruiting

Conditions: Breast Neoplasms
Breast Diseases
Capecitabine
HER2-positive Breast Cancer
HER2 Positive Breast Carcinoma
HER2-positive Advanced Breast With Liver Metastases

Interventions: Drug: Lapatinib
Drug: RC48-ADC
Drug: Capecitabine

First Posted Date: 2018-04-18

Last Posted Date: 2024-02-20

Lead Sponsor: RemeGen Co., Ltd.

Target Recruit Count: 301

Registration Number: NCT03500380

Locations: 🇨🇳
Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China
🇨🇳
Peking University People's Hospital, Beijing, China
🇨🇳
The First Affiliated Hospital of Bengbu Medical College, Bengbu, China

and more 64 locations

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

Phase 2

Conditions: Neoplasms, Breast

Interventions: Biological: Trastuzumab
Drug: Lapatinib
Drug: Paclitaxel
Drug: Epirubicin
Drug: Cyclophosphamide

First Posted Date: 2017-09-06

Last Posted Date: 2017-09-06

Lead Sponsor: Xijing Hospital

Target Recruit Count: 100

Registration Number: NCT03273595

Locations: 🇨🇳
Xijing Hospital, Xi'an, Shanxi, China

Evaluation of Trastuzumab in Combination With Lapatinib or Pertuzumab in Combination With Trastuzumab-Emtansine to Treat Patients With HER2-positive Metastatic Colorectal Cancer

Phase 2

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Pertuzumab, trastuzumab-emtansine
Drug: Trastuzumab, Lapatinib

First Posted Date: 2017-07-21

Last Posted Date: 2018-10-30

Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Target Recruit Count: 54

Registration Number: NCT03225937

Locations: 🇮🇹
AOU Città della Salute e della Scienza di Torino, Torino, Italy
🇮🇹
Fondazione del Piemonte per l'Oncologia - IRCCS, Candiolo, Please Select, Italy
🇮🇹
Grande Ospedale Metropolitano Niguarda, Milano, Italy

and more 4 locations

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

Phase 3

Completed

Conditions: Breast Cancer

Interventions: Biological: Trastuzumab Emtansine
Drug: Lapatinib
Drug: Capecitabine

First Posted Date: 2017-03-21

Last Posted Date: 2023-05-06

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 351

Registration Number: NCT03084939

Locations: 🇨🇳
Beijing Hospital, Beijing City, China
🇨🇳
Beijing Cancer Hospital, Beijing, China
🇨🇳
Changzhou First People's Hospital, Changzhou, China

and more 15 locations

Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)

Phase 3

Conditions: HER2 Positive Metastatic Breast Cancer

Interventions: Drug: Pyrotinib Plus Capecitabine
Drug: Lapatinib Plus Capecitabine

First Posted Date: 2017-03-15

Last Posted Date: 2020-06-18

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 240

Registration Number: NCT03080805

Locations: 🇨🇳
Cancer Institute and Hospital,Chinese Academy of Medical Science, Beijing, Beijing, China

Drug Development Updates

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