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 in Treating Patients With Recurrent Glioblastoma Multiforme

Phase 1

Completed

Conditions: Brain and Central Nervous System Tumors

First Posted Date: 2004-12-09

Last Posted Date: 2014-01-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT00099060

Locations: 🇨🇦
British Columbia Cancer Agency - Centre for the Southern Interior, Kelowna, British Columbia, Canada
🇨🇦
British Columbia Cancer Agency - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
🇨🇦
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada

and more 3 locations

Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases

Phase 2

Completed

Conditions: Central Nervous System Metastases
HER2-positive Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Tumors Metastatic to Brain

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis
Procedure: quality-of-life assessment
Other: questionnaire administration

First Posted Date: 2004-12-08

Last Posted Date: 2013-06-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 37

Registration Number: NCT00098605

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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

Phase 2

Completed

Conditions: Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Squamous Cell Carcinoma of the Hypopharynx
Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity
Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Squamous Cell Carcinoma of the Larynx
Recurrent Squamous Cell Carcinoma of the Nasopharynx
Recurrent Squamous Cell Carcinoma of the Oropharynx
Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
Salivary Gland Squamous Cell Carcinoma
Stage IV Squamous Cell Carcinoma of the Hypopharynx

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

First Posted Date: 2004-12-08

Last Posted Date: 2014-01-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 88

Registration Number: NCT00098631

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

Phase 2

Completed

Conditions: Recurrent Endometrial Carcinoma

Interventions: Drug: lapatinib ditosylate

First Posted Date: 2004-11-10

Last Posted Date: 2019-07-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 31

Registration Number: NCT00096447

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

Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors

Phase 1

Completed

Conditions: Recurrent Childhood Anaplastic Astrocytoma
Recurrent Childhood Brain Stem Glioma
Recurrent Childhood Ependymoma
Recurrent Childhood Giant Cell Glioblastoma
Recurrent Childhood Glioblastoma
Recurrent Childhood Gliosarcoma
Recurrent Childhood Medulloblastoma
Recurrent Childhood Oligodendroglioma

Interventions: Drug: lapatinib ditosylate
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: positron emission tomography
Procedure: magnetic resonance imaging

First Posted Date: 2004-11-09

Last Posted Date: 2014-05-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 52

Registration Number: NCT00095940

Locations: 🇺🇸
Pediatric Brain Tumor Consortium, Memphis, Tennessee, United States

Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer

Phase 2

Completed

Conditions: Recurrent Prostate Cancer
Stage IV Prostate Cancer

Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

First Posted Date: 2004-11-08

Last Posted Date: 2013-05-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 41

Registration Number: NCT00095667

Locations: 🇨🇦
Princess Margaret Hospital Phase 2 Consortium, Toronto, Ontario, Canada

Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers

Phase 2

Completed

Conditions: High-grade Salivary Gland Mucoepidermoid Carcinoma
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Low-grade Salivary Gland Carcinoma
Salivary Gland Malignant Mixed Cell Type Tumor
Low-grade Salivary Gland Mucoepidermoid Carcinoma
Salivary Gland Adenoid Cystic Carcinoma
High-grade Salivary Gland Carcinoma
Recurrent Salivary Gland Cancer
Salivary Gland Acinic Cell Tumor
Salivary Gland Adenocarcinoma