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...

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

Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer
Metastatic Breast Cancer

Interventions: Drug: Lapatinib
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Pegfilgrastim
Drug: Filgrastim
Drug: Dexamethasone
Drug: Trastuzumab

First Posted Date: 2006-11-27

Last Posted Date: 2017-12-22

Lead Sponsor: George Albert Fisher

Target Recruit Count: 21

Registration Number: NCT00404066

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States
🇺🇸
Santa Clara Valley Medical Center, San Jose, California, United States

Pazopanib (VOTRIENT) Plus Paclitaxel (TAXOL), Pazopanib Plus Paclitaxel (TAXOL) Plus Carboplatin (PARAPLATIN), and Pazopanib Plus Paclitaxel (TAXOL) Plus Lapatinib (TYKERB)

Phase 1

Completed

Conditions: Neoplasms, Breast

Interventions: Drug: Pazopanib
Drug: paclitaxel
Drug: Lapatinib
Drug: carboplatin

First Posted Date: 2006-10-13

Last Posted Date: 2017-11-17

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 86

Registration Number: NCT00388076

Locations: 🇺🇸
GSK Investigational Site, Nashville, Tennessee, United States

Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer

Phase 3

Completed

Conditions: Neoplasms, Breast

Interventions: Other: placebo
Drug: lapatinib

First Posted Date: 2006-09-11

Last Posted Date: 2014-08-18

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 3166

Registration Number: NCT00374322

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

Combination Of Lapatinib With Carboplatin, Paclitaxel, and With or Without Trastuzumab In Metastatic Breast Cancer.

Phase 1

Completed

Conditions: Neoplasms, Breast

Interventions: Drug: lapatinib
Drug: carboplatin
Drug: paclitaxel
Drug: trastuzumab

First Posted Date: 2006-08-23

Last Posted Date: 2020-09-09

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 31

Registration Number: NCT00367471

Locations: 🇺🇸
Novartis Investigative Site, Greensboro, North Carolina, United States

Pharmacokinetics And Pharmacodynamics Of Lapatinib In Two Dosing Regimens In Treatment-naive Patients With Breast Cancer

Phase 1

Completed

Conditions: Neoplasms, Breast

Interventions: Drug: lapatinib

First Posted Date: 2006-08-01

Last Posted Date: 2017-11-13

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 28

Registration Number: NCT00359190

Locations: 🇮🇱
GSK Investigational Site, Zrifin, Israel

Pazopanib In Combination With Lapatinib In Adult Patients With Relapsed Malignant Glioma

Phase 2

Completed

Conditions: Glioma

Interventions: Drug: pazopanib
Drug: lapatinib

First Posted Date: 2006-07-11

Last Posted Date: 2013-04-19

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 75

Registration Number: NCT00350727

Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy

Phase 2

Withdrawn

Conditions: Breast Cancer

First Posted Date: 2006-06-23

Last Posted Date: 2015-12-11

Lead Sponsor: University of Pennsylvania

Registration Number: NCT00343759

Locations: 🇺🇸
Abramson Cancer Center of University of Pennsylvania, Philadelphia, Pennsylvania, United States

Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer

Phase 3

Completed

Conditions: Neoplasms, Breast

Interventions: Drug: Lapatinib
Biological: Trastuzumab

First Posted Date: 2006-05-03

Last Posted Date: 2016-02-26

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 296

Registration Number: NCT00320385

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

GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

Phase 2

Completed

Conditions: Neoplasms, Breast

Interventions: Drug: lapatinib

First Posted Date: 2006-05-03

Last Posted Date: 2019-01-31

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 62

Registration Number: NCT00320411

Locations: GSK Investigational Site

Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

Phase 1

Terminated

Conditions: Ovarian Cancer

First Posted Date: 2006-04-24

Last Posted Date: 2009-12-15

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 12

Registration Number: NCT00317434

Locations: 🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

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