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
-

Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China

Phase 3
Terminated
Conditions
Neoplasms, Breast
Interventions
First Posted Date
2007-07-27
Last Posted Date
2021-09-21
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
52
Registration Number
NCT00508274
Locations
🇭🇰

Novartis Investigative Site, Shatin, Hong Kong

Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer

Phase 2
Terminated
Conditions
Breast Cancer
Metastatic Breast Cancer
Advanced Breast Cancer
HER2/Neu-positive Breast Cancer
Interventions
First Posted Date
2007-07-04
Last Posted Date
2017-03-21
Lead Sponsor
Rutgers, The State University of New Jersey
Target Recruit Count
11
Registration Number
NCT00496366
Locations
🇺🇸

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

🇺🇸

Rutgers Cancer Institute of New Jersey at Hamilton, Hamilton, New Jersey, United States

Valproic Acid-Based 2-Agent Oral Regimens for Patients With Advanced Solid Tumor

First Posted Date
2007-07-03
Last Posted Date
2012-10-18
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
204
Registration Number
NCT00495872
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

Phase 3
Completed
Conditions
Neoplasms, Breast
Interventions
Drug: Lapatinib
Biological: Trastuzumab
First Posted Date
2007-06-22
Last Posted Date
2021-07-23
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
8382
Registration Number
NCT00490139
Locations
🇬🇧

Novartis Investigative Site, Worthing, United Kingdom

Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy

Phase 2
Terminated
Conditions
Head and Neck Cancers
Head and Neck Cancer
Carcinoma, Squamous Cell
Interventions
Drug: Lapatinib
Procedure: Radiotherapy (radiation)
Device: G.E. Healthcare 1.5T MR, systems revision 12.0 M5
Device: DCE-MRI
First Posted Date
2007-06-22
Last Posted Date
2017-03-06
Lead Sponsor
Quynh-Thu Le
Target Recruit Count
17
Registration Number
NCT00490061
Locations
🇺🇸

Beth Israel, New York, New York, United States

🇺🇸

Duke University, Durham, North Carolina, United States

🇺🇸

University of Wisconsin Cancer Center, Madison, Wisconsin, United States

and more 2 locations

A Study of AC Followed by a Combination of Paclitaxel Plus Trastuzumab or Lapatinib or Both Given Before Surgery to Patients With Operable HER2 Positive Invasive Breast Cancer

First Posted Date
2007-06-15
Last Posted Date
2016-06-06
Lead Sponsor
NSABP Foundation Inc
Target Recruit Count
529
Registration Number
NCT00486668
Locations
🇺🇸

CCOP, William Beaumont Hospital, Royal Oak, Michigan, United States

🇺🇸

CCOP, Hematology-Oncology Associates of CNY, Syracuse, New York, United States

🇺🇸

Lehigh Valley Hospital, Allentown, Pennsylvania, United States

and more 107 locations

Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

Phase 3
Completed
Conditions
Neoplasms, Gastrointestinal Tract
Interventions
First Posted Date
2007-06-15
Last Posted Date
2013-06-20
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
273
Registration Number
NCT00486954
Locations
🇨🇳

GSK Investigational Site, Tau-Yuan County, Taiwan

Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer

Phase 2
Terminated
Conditions
Relapsed Breast Cancer
Neoplasms, Breast
Interventions
First Posted Date
2007-05-28
Last Posted Date
2012-06-05
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
9
Registration Number
NCT00479856
Locations
🇺🇸

GSK Investigational Site, Fairfax, Virginia, United States

Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

Phase 2
Completed
Conditions
Neoplasms, Breast
Metastatic Breast Cancer
Interventions
First Posted Date
2007-05-23
Last Posted Date
2018-09-17
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
51
Registration Number
NCT00477464
Locations
🇯🇵

GSK Investigational Site, Tokyo, Japan

Lapatinib in Combination With Radiation Therapy in Patients With Brain Metastases From HER2-Positive Breast Cancer

Phase 1
Completed
Conditions
Breast Cancer
Brain Metastases
Interventions
Drug: Lapatinib
Procedure: Whole Brain Radiation
Drug: Herceptin
First Posted Date
2007-05-08
Last Posted Date
2014-05-22
Lead Sponsor
Nancy Lin, MD
Target Recruit Count
35
Registration Number
NCT00470847
Locations
🇺🇸

Brigham and Women's Hospital, Boston, Massachusetts, United States

🇺🇸

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

🇺🇸

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

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