MedPath

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
-

Study of Foretinib in Combination With Lapatinib in Patients With Metastatic Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-06-07
Last Posted Date
2023-08-04
Lead Sponsor
NCIC Clinical Trials Group
Target Recruit Count
19
Registration Number
NCT01138384
Locations
🇨🇦

BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada

🇨🇦

Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada

🇨🇦

London Regional Cancer Program, London, Ontario, Canada

and more 2 locations

GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers

Phase 1
Terminated
Conditions
Breast Cancer
Neoplasm Metastasis
Interventions
First Posted Date
2010-05-07
Last Posted Date
2019-11-13
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
12
Registration Number
NCT01118975
Locations
🇺🇸

University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States

Lapatinib With Sirolimus or Metformin

Phase 1
Completed
Conditions
Advanced Cancers
Interventions
First Posted Date
2010-03-16
Last Posted Date
2015-11-11
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
111
Registration Number
NCT01087983
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2010-02-15
Last Posted Date
2015-10-12
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
4
Registration Number
NCT01068704
Locations
🇺🇸

Texas Oncology-Abilene, Abilene, Texas, United States

🇺🇸

Texas Oncology-Beaumont, Beaumont, Texas, United States

🇺🇸

Us Oncology Central Pharmacy, Fort Worth, Texas, United States

and more 2 locations

Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Interventions
First Posted Date
2010-01-08
Last Posted Date
2012-09-25
Lead Sponsor
Centre Georges Francois Leclerc
Target Recruit Count
17
Registration Number
NCT01044485
Locations
🇫🇷

Centre Georges François Leclerc, Dijon, Bourgogne, France

Lapatinib in Combination With Vinorelbine

Phase 2
Completed
Conditions
Cancer
Interventions
First Posted Date
2009-11-16
Last Posted Date
2017-05-31
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
112
Registration Number
NCT01013740
Locations
🇪🇸

Novartis Investigative Site, Zamora, Spain

ELBA: Exemestane and Lapatinib in Advanced Breast Cancer

Phase 2
Withdrawn
Conditions
Breast Cancer
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
Breast Cancer
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
Neoplasms, Breast
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
Neurofibromatosis 2
Vestibular Schwannoma
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

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