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

Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen

Phase 2

Completed

Conditions: Male Breast Carcinoma
Estrogen Receptor Positive
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Progesterone Receptor Positive
Stage IV Breast Cancer

Interventions: Other: Laboratory Biomarker Analysis
Drug: Lapatinib Ditosylate
Drug: Tamoxifen Citrate

First Posted Date: 2005-07-11

Last Posted Date: 2017-12-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 19

Registration Number: NCT00118157

Locations: 🇺🇸
Harper University Hospital - DMC, Detroit, Michigan, United States
🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Phase 2

Completed

Conditions: Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Salivary Gland Cancer
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Verrucous Carcinoma of the Oral Cavity
Salivary Gland Squamous Cell Carcinoma
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Stage IVA Salivary Gland Cancer

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-06-14

Last Posted Date: 2015-04-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT00114283

Locations: 🇺🇸
University of Virginia, Charlottesville, Virginia, United States

Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

Phase 2

Completed

Conditions: Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-06-08

Last Posted Date: 2019-07-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 28

Registration Number: NCT00113373

Locations: 🇺🇸
Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

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

Phase 2

Completed

Conditions: Neoplasms, Breast

Interventions: Drug: Lapatinib
Drug: Paclitaxel

First Posted Date: 2005-05-26

Last Posted Date: 2017-05-31

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 49

Registration Number: NCT00111787

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

Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer

Phase 2

Completed

Conditions: Adult Primary Hepatocellular Carcinoma
Localized Unresectable Adult Primary Liver Cancer
Unresectable Gallbladder Cancer
Advanced Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Unresectable Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Recurrent Extrahepatic Bile Duct Cancer

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-04-06

Last Posted Date: 2015-04-29

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 26

Registration Number: NCT00107536

Locations: 🇺🇸
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus, Ohio, United States

GW572016 to Treat Recurrent Malignant Brain Tumors

Phase 2

Completed

Conditions: Glioma
Brain Tumor
Glioblastoma Multiforme
GBM
Gliosarcoma
GS

First Posted Date: 2005-04-04

Last Posted Date: 2018-07-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 9

Registration Number: NCT00107003

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

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

Phase 2

Completed

Conditions: Neoplasms, Breast

Interventions: Drug: lapatinib

First Posted Date: 2005-03-21

Last Posted Date: 2015-09-28

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 126

Registration Number: NCT00105950

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

S0413 Lapatinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer

Phase 2

Completed

Conditions: Diffuse Adenocarcinoma of the Stomach
Intestinal Adenocarcinoma of the Stomach
Mixed Adenocarcinoma of the Stomach
Recurrent Gastric Cancer
Stage III Gastric Cancer
Stage IV Gastric Cancer

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-02-08

Last Posted Date: 2013-01-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 40

Registration Number: NCT00103324

Locations: 🇺🇸
Southwest Oncology Group, San Antonio, Texas, United States

Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

Phase 2

Completed

Conditions: Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage III Prostate Cancer
Stage IIB Prostate Cancer
Recurrent Prostate Cancer

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-02-08

Last Posted Date: 2014-09-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 49

Registration Number: NCT00103194

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Localized Unresectable Adult Primary Liver Cancer
Advanced Adult Primary Liver Cancer
Recurrent Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Adult Primary Hepatocellular Carcinoma
Recurrent Adult Primary Liver Cancer
Recurrent Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

First Posted Date: 2005-01-10

Last Posted Date: 2018-04-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 57

Registration Number: NCT00101036

Locations: 🇺🇸
UC Davis Comprehensive Cancer Center, Sacramento, California, United States

Drug Development Updates

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