Lapatinib

Generic Name
Lapatinib
Brand Names
Tykerb, Tyverb
Drug Type
Small Molecule
Chemical Formula
C29H26ClFN4O4S
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
-

ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2009-11-01
Last Posted Date
2012-07-13
Lead Sponsor
National Cancer Institute, Naples
Registration Number
NCT01005641
Locations
🇮🇹

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, Italy

🇮🇹

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli, Italy

🇮🇹

Ospedale S. Luca ASL SA 3, Vallo della Lucania, Italy

Extension Study of Lapatinib Plus Herceptin With or Without Endocrine Therapy

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2009-10-22
Last Posted Date
2023-06-18
Lead Sponsor
Baylor Breast Care Center
Target Recruit Count
128
Registration Number
NCT00999804
Locations
🇺🇸

Baylor College of Medicine Lester and Sue Smith Breast Center, Houston, Texas, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

University of Alabama - Birmingham, Birmingham, Alabama, United States

and more 5 locations

A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib

Phase 1
Completed
Conditions
Interventions
First Posted Date
2009-10-16
Last Posted Date
2017-11-13
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
158
Registration Number
NCT00996762
Locations
🇰🇷

GSK Investigational Site, Seoul, Korea, Republic of

Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-09-09
Last Posted Date
2016-03-22
Lead Sponsor
NYU Langone Health
Target Recruit Count
21
Registration Number
NCT00973739
Locations
🇺🇸

New York University School of Medicine, New York, New York, United States

Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2009-08-31
Last Posted Date
2019-06-10
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
37
Registration Number
NCT00968968
Locations
🇨🇦

Novartis Investigative Site, Rimouski, Quebec, Canada

A Study of MK-2206 in Combination With Trastuzumab and Lapatinib for the Treatment of HER2+ Solid Tumors (MK-2206-015)

First Posted Date
2009-08-21
Last Posted Date
2024-06-04
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
33
Registration Number
NCT00963547

Ketoconazole, Hydrocortisone, Dutasteride and Lapatinib (KHAD-L) in Prostate Cancer

First Posted Date
2009-08-06
Last Posted Date
2018-09-04
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
11
Registration Number
NCT00953576
Locations
🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study to Assess dHER2+AS15 Cancer Vaccine Given in Combination With Lapatinib to Patients With Metastatic Breast Cancer

Phase 1
Completed
Conditions
First Posted Date
2009-08-06
Last Posted Date
2021-12-20
Lead Sponsor
Michael Morse, MD
Target Recruit Count
12
Registration Number
NCT00952692
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-07-15
Last Posted Date
2020-01-22
Lead Sponsor
Cedars-Sinai Medical Center
Target Recruit Count
9
Registration Number
NCT00939523
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

🇺🇸

Cedars-Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer

Phase 2
Terminated
Conditions
First Posted Date
2009-04-28
Last Posted Date
2009-04-28
Lead Sponsor
Centre Francois Baclesse
Target Recruit Count
39
Registration Number
NCT00888810
Locations
🇫🇷

Centre François Baclesse, Caen, Calvados, France

🇫🇷

Centre G-F Leclerc, Dijon, France

🇫🇷

Institut Bergonié, Bordeaux, France

and more 18 locations
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