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lapatinib / Generic mfg.
CHERLOB, NCT00429299: Neoadjuvant Study With Chemotherapy, Lapatinib And Trastuzumab In Breast Cancer

Checkmark ESMO 2014
Sep 2014 - Sep 2014: ESMO 2014
Checkmark P2 data - ESMO 2012
Sep 2012 - Sep 2012: P2 data - ESMO 2012
Checkmark P2 data
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Completed
2b
121
Europe
lapatinib, Tyverb/Tykerb, trastuzumab, Herceptin, paclitaxel, Taxol, fluorouracil, epidoxorubicin, cyclophosphamide
GlaxoSmithKline
Neoplasms, Breast
06/12
06/12
NCT02338245: Study of ASLAN001 in Combination With Capecitabine in MBC That Has Failed on Prior Trastuzumab

Completed
2a/2b
200
RoW
ASLAN001, Lapatinib, Tykerb, Capecitabine, Xeloda
Aslan Pharmaceuticals
Metastatic Breast Cancer
05/16
08/16
NCT00044343: GW572016, An Oral Drug For Colorectal Cancer Patients Having Prior Therapy With 5-FU Plus CPT-11 And/Or Oxaliplatin

Completed
2
80
US, Canada
lapatinib
GlaxoSmithKline
Colorectal Cancer
10/03
10/03
NCT00062686: GW572016 For Treatment Of Refractory Metastatic Breast Cancer

Completed
2
200
Europe, RoW
GW572016
GlaxoSmithKline
Neoplasms, Breast
02/05
02/05
NCT00051103: Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

Completed
2
US
Investigational Cancer Drug
GlaxoSmithKline
Metastatic Breast Cancer, Neoplasms, Breast
06/05
06/05
NCT00044330: GW572016, An Oral Drug For Women With Refractory Metastatic Breast Cancer After First-line Or Second-line Herceptin

Completed
2
80
US
GW572016
GlaxoSmithKline
Metastatic Breast Cancer
06/05
06/05
NCT00239200: Lapatinib (GW572016) for Metastatic or Recurrent Squamous Cell Carcinoma Esophagus

Terminated
2
29
US
Lapatinib
University of Michigan Rogel Cancer Center
Metastatic or Recurrent Squamous Cell Carcinoma of the Esophagus
06/06
09/07
NCT00098605: Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases

Completed
2
37
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis, quality-of-life assessment, quality of life assessment, questionnaire administration
National Cancer Institute (NCI)
Central Nervous System Metastases, HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer, Tumors Metastatic to Brain
09/06
 
NCT00114283: Lapatinib Ditosylate in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

Completed
2
30
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI)
Recurrent Salivary Gland Cancer, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, 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, Recurrent Verrucous Carcinoma of the Larynx, Recurrent Verrucous Carcinoma of the Oral Cavity, Salivary Gland Squamous Cell Carcinoma, Stage IV Squamous Cell Carcinoma of the Hypopharynx, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IVA Salivary Gland Cancer, Stage IVA Squamous Cell Carcinoma of the Larynx, Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVA Squamous Cell Carcinoma of the Oropharynx, Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVA Verrucous Carcinoma of the Larynx, Stage IVA Verrucous Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVB Squamous Cell Carcinoma of the Larynx, Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVB Squamous Cell Carcinoma of the Oropharynx, Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVB Verrucous Carcinoma of the Larynx, Stage IVB Verrucous Carcinoma of the Oral Cavity, Stage IVC Salivary Gland Cancer, Stage IVC Squamous Cell Carcinoma of the Larynx, Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IVC Squamous Cell Carcinoma of the Oropharynx, Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Stage IVC Verrucous Carcinoma of the Larynx, Stage IVC Verrucous Carcinoma of the Oral Cavity, Tongue Cancer
10/06
10/06
NCT00111787 / 2004-001905-93: Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

Completed
2
49
US, Canada, Europe, RoW
Lapatinib, Paclitaxel
GlaxoSmithKline
Neoplasms, Breast
11/06
11/06
NCT00098631: Lapatinib in Treating Patients With Recurrent and/or Metastatic Head and Neck Cancer

Checkmark P2 Data
Mar 2012 - Mar 2012: P2 Data
Completed
2
88
US
lapatinib ditosylate, laboratory biomarker analysis
National Cancer Institute (NCI)
Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Metastatic Squamous Neck Cancer With Occult Primary, Recurrent Squamous Cell Carcinoma of the Hypopharynx, Recurrent Squamous Cell Carcinoma of the Larynx, Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity, 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, Stage IV Squamous Cell Carcinoma of the Larynx, Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage IV Squamous Cell Carcinoma of the Nasopharynx, Stage IV Squamous Cell Carcinoma of the Oropharynx, Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity, Untreated Metastatic Squamous Neck Cancer With Occult Primary
12/06
 
NCT00462956: GW572016 In Patients With Advanced Or Metastatic Breast Cancer

Completed
2
59
Japan, RoW
Tykerb
GlaxoSmithKline
Neoplasms, Breast
12/06
12/06
NCT00103324: S0413 Lapatinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer

Completed
2
40
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI)
Diffuse Adenocarcinoma of the Stomach, Intestinal Adenocarcinoma of the Stomach, Mixed Adenocarcinoma of the Stomach, Recurrent Gastric Cancer, Stage III Gastric Cancer, Stage IV Gastric Cancer
05/07
 
NCT00259987: Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

Completed
2
24
US, Europe, RoW
Lapatinib (GW572016) oral tablets
GlaxoSmithKline
Adenocarcinoma
 
05/07
NCT00105950 / 2004-001906-29: Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer

Completed
2
126
US, Canada, Europe, RoW
lapatinib
GlaxoSmithKline
Neoplasms, Breast
09/07
05/10
NCT00263588 / 2005-003944-68: Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer

Completed
2
242
Europe, Canada, Japan, US, RoW
lapatinib
Novartis Pharmaceuticals
Neoplasms, Breast
09/07
03/18
NCT00095667: Lapatinib in Treating Patients With Recurrent or Metastatic Prostate Cancer

Completed
2
41
Canada
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI)
Recurrent Prostate Cancer, Stage IV Prostate Cancer
11/07
 
NCT00371566 / 2005-002485-11: A Study Of Lapatinib Versus Placebo Followed By Chemoradiation In Patients With Locally Advanced Head And Neck Cancer

Completed
2
107
Europe, RoW
Lapatinib oral tablets, platinum - based chemotherapy, radiotherapy, Placebo
GlaxoSmithKline
Squamous Cell Carcinoma of Head and Neck
12/07
12/07
NCT00107003: GW572016 to Treat Recurrent Malignant Brain Tumors

Completed
2
9
US
lapatinib ditosylate, Adjuvant therapy, Conventional surgery, Neoadjuvant therapy
National Cancer Institute (NCI)
Glioma, Brain Tumor, Glioblastoma Multiforme, GBM, Gliosarcoma, GS
12/07
11/12
NCT00089999: Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Completed
2
138
US, Europe, RoW
Lapatinib
GlaxoSmithKline
Neoplasms, Breast
03/08
03/08
NCT00356811 / 2005-003945-16: Lapatinib Combined With Paclitaxel For Patients With First-Line ErbB2-Amplified Metastatic Breast Cancer

Completed
2
57
Europe, RoW
Lapatinib oral tablets, Tykerb/ Tyverb, Paclitaxel infusion, Taxol
GlaxoSmithKline
Neoplasms, Breast
03/08
12/13
NCT00073008: A Study Of Oral GW572016 In Advanced Or Metastatic Non-Small Cell Lung Cancer

Terminated
2
131
US, Canada
GW572016 (lapatinib)
GlaxoSmithKline
Lung Cancer, Non-Small Cell
07/08
07/08
NCT00430781 / 2006-000236-27: Pazopanib Plus Lapatinib Compared to Lapatinib Alone and Pazopanib Alone In Subjects With Metastatic Cervical Cancer

Completed
2
228
US, Canada, Europe, RoW
pazopanib (GW786034), lapatinib (GW572016)
GlaxoSmithKline
Neoplasms, Uterine Cervix, Metastatic Cervical Cancer
07/08
07/11
NCT00444535: Lapatinib and Bevacizumab for Metastatic Breast Cancer

Completed
2
52
US
lapatinib, Tykerb/Tyverb, bevacizumab
Novartis Pharmaceuticals
Neoplasms, Breast
07/08
06/20
NCT00347919 / 2005-004350-28: Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer

Checkmark +lapatinib (Breast)
Jan 2013 - Jan 2013: +lapatinib (Breast)
Checkmark Data
Feb 2011 - Feb 2011: Data
Completed
2
189
US, Canada, Europe, RoW
pazopanib (GW786034) 400 mg, lapatinib (GW572016) 1500 mg, lapatinib (GW572016) 1000 mg, pazopanib (GW786034) 800 mg
GlaxoSmithKline
Neoplasms, Breast
08/08
03/15
NCT00101036: Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery

Completed
2
57
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI)
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
01/09
01/09
NCT00437073: Brain Metastases In ErbB2-Positive Breast Cancer

Terminated
2
22
US, Canada, Europe, RoW
capecitabine, Xeloda, topotecan, Hycamtin, lapatinib, Tykerb/Tyverb
GlaxoSmithKline
Neoplasms, Breast
01/09
02/10
NCT00095563: Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers

Completed
2
40
Canada
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI)
High-grade Salivary Gland Carcinoma, High-grade Salivary Gland Mucoepidermoid Carcinoma, Low-grade Salivary Gland Carcinoma, Low-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor, Salivary Gland Adenocarcinoma, Salivary Gland Adenoid Cystic Carcinoma, Salivary Gland Malignant Mixed Cell Type Tumor
02/09
06/09
NCT00436644: Lapatinib and Topotecan in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Did Not Respond to Cisplatin or Carboplatin

Completed
2
18
US
Lapatinib, Tykerb, Topotecan, Hycamptin
Mayo Clinic, National Cancer Institute (NCI)
Ovarian Cancer, Peritoneal Cavity Cancer
03/09
11/12
NCT00320411: GW572016 In Patients With ErbB2 Over - Expressing Advanced Or Metastatic Breast Cancer

Completed
2
62
Japan, RoW
lapatinib
GlaxoSmithKline
Neoplasms, Breast
04/09
04/09
NCT00436566: Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery

Checkmark +trastuzumab, paclitaxel as adjuant therapy
Mar 2013 - Mar 2013: +trastuzumab, paclitaxel as adjuant therapy
Completed
2
122
US
trastuzumab, cyclophosphamide, doxorubicin hydrochloride, lapatinib ditosylate, paclitaxel, gene expression analysis, reverse transcriptase-polymerase chain reaction, fluorophotometry, laboratory biomarker analysis, mass spectrometry, adjuvant therapy, quality-of-life assessment
Mayo Clinic, National Cancer Institute (NCI)
Breast Cancer, Cardiac Toxicity
04/09
07/19
TOPO-LAPA, NCT00888810 / 2007-005706-44: Efficacy of Topotecan and Lapatinib in Early Recurrent Ovarian or Peritoneal Cancer

Terminated
2
39
Europe
TOPOTECAN, HYCAMTIN, LAPATINIB, TYVERB
Centre Francois Baclesse, GlaxoSmithKline, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Cancer, Ovarian, Relapse, Chemotherapy
 
 
NCT00107536: Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer

Completed
2
26
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI)
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Localized Unresectable Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Extrahepatic Bile Duct Cancer, Recurrent Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Cancer, Unresectable Gallbladder Cancer
05/09
05/09
NCT00343759: Presurgical Therapy With Lapatinib to Explore Molecular Determinants of Response to EGFR/erbB2 Targeted Therapy

Withdrawn
2
0
US
Lapatinib
University of Pennsylvania
Breast Cancer
05/09
12/09
NCT00447226: Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists

Terminated
2
32
US
Oral lapatinib tablets or placebo tablets
GlaxoSmithKline
Cancer
05/09
09/09
NCT00528281 / 2007-002472-34: A Phase II Trial of Lapatinib (TYKERB) + Pemetrexed (ALIMTA) in Advanced Non Small Cell Lung Cancer With an Initial Dose Finding Phase

Completed
2
18
Europe
Lapatinib, Pemetrexed
GlaxoSmithKline
Lung Cancer, Non-Small Cell
05/09
05/09
NCT00387127 / 2005-003767-23: Lapatinib Versus Placebo Given Concurrently With Cisplatin And Radiotherapy In Patients With Unresected Head And Neck Cancer

Checkmark + chemoradiotherapy (HNC)
Dec 2012 - Dec 2012: + chemoradiotherapy (HNC)
Completed
2
67
US, Canada, Europe, RoW
Lapatinib oral tablets, radiotherapy, cisplatin chemotherapy
GlaxoSmithKline
Neoplasms, Head and Neck
06/09
01/14
NCT00574171: Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma

Completed
2
29
US
lapatinib, Tykerb, Capecitabine, Xeloda
University of Wisconsin, Madison, GlaxoSmithKline
Metastatic Colorectal Cancer
08/09
08/09
NCT00479856: Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer

Terminated
2
9
US
Lapatinib, Capecitabine, Docetaxel, nab-Paclitaxel
GlaxoSmithKline
Relapsed Breast Cancer, Neoplasms, Breast
09/09
03/10
APRiCOT-B, NCT00657137: Study to Evaluate Apricoxib in Combination With Lapatinib and Capecitabine in the Treatment of HER2/Neu+ Breast Cancer (TP2001-202)

Terminated
2
12
US
apricoxib + lapatinib + capecitabine, placebo + lapatinib + capecitabine
Tragara Pharmaceuticals, Inc.
Breast Cancer
09/09
09/09
NCT00499681: PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE

Terminated
2
6
US
lapatinib ditosylate, GW572016, letrozole, Femara, placebo
Vanderbilt-Ingram Cancer Center, National Cancer Institute (NCI)
Breast Cancer
10/09
12/10
VEG102857, NCT00350727 / 2006-001278-26: Pazopanib In Combination With Lapatinib In Adult Patients With Relapsed Malignant Glioma

Checkmark P1/2 data in relapsed malignant glioma
Feb 2013 - Feb 2013: P1/2 data in relapsed malignant glioma
Completed
2
75
US, RoW
pazopanib, lapatinib
GlaxoSmithKline
Glioma
12/09
12/09
NCT00496366: Capecitabine (Xeloda) and Lapatinib (Tykerb) as First-line Therapy in HER2/Neu-positive Breast Cancer

Terminated
2
11
US
Capecitabine, Xeloda, Lapatinib, Tykerb
Rutgers, The State University of New Jersey, National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, HER2/Neu-positive Breast Cancer
12/09
03/17
NCT00095940: Lapatinib in Treating Young Patients With Recurrent or Refractory Central Nervous System Tumors

Checkmark In children with refractory CNS malignancies
Jul 2013 - Jul 2013: In children with refractory CNS malignancies
Completed
2
52
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, therapeutic conventional surgery, laboratory biomarker analysis, pharmacological study, pharmacological studies, positron emission tomography, FDG-PET, PET, PET scan, tomography, emission computed, magnetic resonance imaging, MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
National Cancer Institute (NCI)
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
07/10
07/10
LPT109096, NCT00524303: Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.

Checkmark Lapatinib +/- trastuzumab in addition to standard neoadjuvant breast cancer therapy
Dec 2013 - Dec 2013: Lapatinib +/- trastuzumab in addition to standard neoadjuvant breast cancer therapy
Completed
2
100
US
Trastuzumab, Paclitaxel, FEC75, Lapatinib
GlaxoSmithKline
Neoplasms, Breast
10/10
08/15
NCT00404066: Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer

Completed
2
21
US
Lapatinib, GW572016, Doxorubicin, Adriamycin, Adriablastin, Cyclophosphamide, Cytoxan, ASTA, Docetaxel, Taxotere, Pegfilgrastim, Neulasta, Filgrastim, Neupogen, Granulocyte Colony-Stimulating Factor (G-CSF), Dexamethasone, Adexone, Trastuzumab, Herceptin
George Albert Fisher, GlaxoSmithKline, Sanofi
Breast Cancer, Metastatic Breast Cancer
12/10
03/11
NCT00477464: Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

Completed
2
51
Japan
Lapatinib, capecitabine
GlaxoSmithKline
Metastatic Breast Cancer, Neoplasms, Breast
12/10
12/10
NCT00962312: Lapatinib Ditosylate and Capecitabine in Treating Patients With Metastatic Pancreatic Cancer

Completed
2
9
Europe
capecitabine, lapatinib ditosylate
Cancer Trials Ireland
Pancreatic Cancer
12/10
 
NCT00820872: Docetaxel, Carboplatin, Trastuzumab, and Lapatinib in Treating Patients With Early Stage Breast Cancer

Completed
2
30
US
trastuzumab, carboplatin, docetaxel, lapatinib ditosylate
Alliance for Clinical Trials in Oncology, National Cancer Institute (NCI)
Breast Cancer
12/10
08/19
GLICO-0801, NCT01050322: Safety Study in Subjects With Metastatic Breast Cancer Who Progressed After Taxanes Treatment.

Checkmark SABCS 2013
Jan 2014 - Jan 2014: SABCS 2013
Completed
2
142
RoW
Lapatinib Vinorelbine, Lapatinib Capecitabine, Gemcitabine Lapatinib
Latin American Cooperative Oncology Group, GlaxoSmithKline
BRMS1, Performance Status Zero to Two for Beginning the Study, Patient With a Maximum of One Chemotherapy, Patient With Progression After Taxanes
12/10
09/11
NCT01068704 / 2009-016622-13: Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer

Completed
2
4
US, RoW
BMS-690514, Lapatinib, Letrozole
Bristol-Myers Squibb
Breast Cancer
12/10
12/10
ELATE, NCT01205217: Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer

Withdrawn
2
0
Europe
Lapatinib, Trastuzumab, Epirubicin, Cyclophosphamide, Paclitaxel
GlaxoSmithKline
Neoplasms, Breast
12/10
12/10
TBCRC 006, NCT00548184: Lapatinib and Trastuzumab With or Without Endocrine Therapy

Checkmark
Apr 2013 - Apr 2013: 
Completed
2
65
US
Lapatinib, TyKerb, Trastuzumab, Herceptin, Endocrine, Varies
Baylor Breast Care Center, GlaxoSmithKline
Breast Cancer
01/11
01/14
NCT00709761: Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC

Checkmark P2 data
Dec 2012 - Dec 2012: P2 data
Checkmark P2 data-SABCS
Dec 2011 - Dec 2011: P2 data-SABCS
Completed
2
60
US
Lapatinib/nab-Paclitaxel
Novartis Pharmaceuticals
Neoplasms, Breast
01/11
01/18
NCT00096447: Lapatinib in Treating Patients With Recurrent or Persistent Endometrial Cancer

Checkmark P2 data
Aug 2012 - Aug 2012: P2 data
Completed
2
31
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb
National Cancer Institute (NCI), Gynecologic Oncology Group
Recurrent Endometrial Carcinoma
03/11
03/11
NCT00113373: Lapatinib in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Peritoneal Cancer

Completed
2
28
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI), Gynecologic Oncology Group
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
03/11
03/11
NCT00754702: Vinorelbine Metronomic Plus Lapatinib for Overexpressing HER-2 Metastatic Breast Cancer

Terminated
2
16
Europe
Vinorelbine, Navelbine, Lapatinib, Tyverb, Tykerb
University Hospital of Crete
Breast Cancer
03/11
03/11
NCT00777101: Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

Checkmark Neratinib vs. lapatinib+capecitabine in pts with HER2+ adv BC
Aug 2013 - Aug 2013: Neratinib vs. lapatinib+capecitabine in pts with HER2+ adv BC
Checkmark P2 data - SABCS
Dec 2011 - Dec 2011: P2 data - SABCS
Completed
2
233
Canada, Japan, US, Europe, RoW
Neratinib, HKI-272, Lapatinib, Tykerb, Tyverb, Capecitabine, Xeloda
Puma Biotechnology, Inc.
Advanced Breast Cancer, Breast Cancer
03/11
06/18
LETLOB, NCT00422903 / 2006-001907-13: Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer

Checkmark ASCO 2013
May 2013 - May 2013: ASCO 2013
Completed
2
92
Europe
lapatinib, letrozole, placebo
GlaxoSmithKline
Neoplasms, Breast
04/11
04/11
NCT00526669: Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib

Completed
2
68
US, Canada, RoW
Lapatinib and Capecitabine
GlaxoSmithKline
Neoplasms, Gastrointestinal Tract
04/11
01/15
NCT00206427: Neoadjuvant GW572016 to Treat Breast Cancer

Completed
2
49
US
GW572016, TyKerb, Lapatinib, lapatinib
Baylor Breast Care Center, GlaxoSmithKline
Breast Cancer
06/11
02/12
NCT00118157: Lapatinib and Tamoxifen in Treating Patients With Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Tamoxifen

Completed
2
19
US
Laboratory Biomarker Analysis, Lapatinib Ditosylate, Tykerb, Tamoxifen Citrate, Apo-Tamox, Clonoxifen, Dignotamoxi, Ebefen, Emblon, Estroxyn, Fentamox, Gen-Tamoxifen, Genox, ICI 46,474, ICI-46474, Jenoxifen, Kessar, Ledertam, Lesporene, Nolgen, Noltam, Nolvadex, Nolvadex-D, Nourytam, Novo-Tamoxifen, Novofen, Noxitem, Oestrifen, Oncotam, PMS-Tamoxifen, Soltamox, TAM, Tamax, Tamaxin, Tamifen, Tamizam, Tamofen, Tamoxasta, Tamoxifeni Citras, Zemide
National Cancer Institute (NCI)
Estrogen Receptor Positive, Male Breast Carcinoma, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
07/11
09/14
NCT00482391: Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer

Checkmark ASCO-BC 2013
Sep 2013 - Sep 2013: ASCO-BC 2013
Checkmark ASCO 2013
May 2013 - May 2013: ASCO 2013
Completed
2
95
US
trastuzumab, cyclophosphamide, doxorubicin hydrochloride, lapatinib ditosylate, paclitaxel, laboratory biomarker analysis
Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI), Dana-Farber Cancer Institute, GlaxoSmithKline
Breast Cancer
07/11
07/11
NCT00820924: Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells

Checkmark ASCO 2013
May 2013 - May 2013: ASCO 2013
Terminated
2
23
Europe
LAPATINIB
GlaxoSmithKline
Neoplasms, Breast
07/11
07/11
MAPLE, NCT00299286: Short-term Presurgical Study to Assess Molecular Predictors of Lapatinib's Effects in Primary Breast Cancer

Checkmark P2 data: SABCS 2012
Dec 2012 - Dec 2012: P2 data: SABCS 2012
Completed
2
121
Europe
Lapatinib, Tyverb, Lapatinib-Placebo
Institute of Cancer Research, United Kingdom, GlaxoSmithKline
Breast Cancer
08/11
08/11
NCT00826267: 6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab

Checkmark P2 data - ASCO
Jun 2012 - Jun 2012: P2 data - ASCO
Completed
2
29
US, RoW
lapatinib, BIBW 2992, trastuzumab
Boehringer Ingelheim
Breast Neoplasms
08/11
 
NCT00225758: Lapatinib in Metastatic Breast Cancer Resistant to Hormone Therapy

Terminated
2
27
US
Lapatinib, Tykerb
Gary Schwartz, University of Colorado, Denver, North Shore University Hospital
Metastatic Breast Cancer
10/11
10/11
ELBA, NCT01005641: Exemestane and Lapatinib in Advanced Breast Cancer

Withdrawn
2
0
Europe
exemestane, lapatinib
National Cancer Institute, Naples
Breast Cancer
10/11
03/12
NCT00694252 / 2007-005400-40: Lapatinib and Circulating Tumor Cells in Breast Cancer

Checkmark ASCO 2013
May 2013 - May 2013: ASCO 2013
Completed
2
20
Europe
Lapatinib, Tykerb, Tyverb, GW572016
University Hospital of Crete
Metastatic Breast Cancer
11/11
11/11
NCT00841828 / 2007-007031-13: Trastuzumab Versus Lapatinib as Neoadjuvant Treatment for Her2+ Patients

Checkmark In HER2+ve BC pts
Jan 2014 - Jan 2014: In HER2+ve BC pts
Checkmark P2 data-SABCS
Dec 2011 - Dec 2011: P2 data-SABCS
Completed
2
102
Europe
Epirubicin, Ellence, Pharmorubicin, Cyclophosphamide, Cytoxan, Neosar, Endoxan, Docetaxel, Taxotere, Lapatinib, Tykerb, Trastuzumab, Herceptin
Spanish Breast Cancer Research Group, GlaxoSmithKline
Breast Cancer
12/11
12/13
HERLAP, NCT00842998 / 2008-001916-18: Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer

Checkmark SABCS 2013
Jan 2014 - Jan 2014: SABCS 2013
Unknown status
2
120
Europe
Trastuzumab or Lapatinib
Azienda Ospedaliera Ordine Mauriziano di Torino
Metastatic Breast Cancer
12/11
12/11
GERICO09, NCT01262469 / 2009-015981-73: Evaluating Lapatinib + Capecitabine in Patients Aged 70 and Over With HER2 Metastatic Breast Cancer.

Completed
2
4
Europe
lapatinib + capecitabine, Tyverb, Xeloda
UNICANCER, GlaxoSmithKline
Metastatic Breast Cancer, 70 Years Old Patients and Over, After One Line of Chemotherapy With Trastuzumab
12/11
11/13
ACTRN12610000347066: Lapatinib and vinorelbine in women with previously treated breast cancer

Completed
2
20
 
Breast Cancer Research Centre of WA, Investigator Initiated Research Grant from GlaxoSmithKline
Metastatic Breast Cancer, breast cancer
 
 
NCT00967031 / 2008-001084-10: Lapatinib Ditosylate and Capecitabine in Treating Patients With Stage IV Breast Cancer and Brain Metastases

Checkmark ESMO 2013
Sep 2013 - Sep 2013: ESMO 2013
Checkmark P2 biomarker data: SABCS 2012
Dec 2012 - Dec 2012: P2 biomarker data: SABCS 2012
Checkmark P2 data
More
Completed
2
45
Europe
capecitabine, lapatinib ditosylate, circulating tumor cell analysis, laboratory biomarker analysis
UNICANCER
Breast Cancer, Metastatic Cancer
02/12
 
NCT01128543: Lapatinib in Combination With Vinorelbine

Completed
2
29
RoW
lapatinib and Vinorelbine
GlaxoSmithKline
Cancer
03/12
03/12
NCT00709618: Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects

Checkmark ASCO 2013
May 2013 - May 2013: ASCO 2013
Terminated
2
44
US
Lapatinib, Vinorelbine, Lapatinib, Vinorelbine
GlaxoSmithKline
Neoplasms, Breast
05/12
05/12
NCT00903656 / 2008-004530-25: Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy

Terminated
2
24
Europe
doxorubicinhydrochloride, Lapatinib
Arbeitsgemeinschaft medikamentoese Tumortherapie, GlaxoSmithKline
Metastatic Breast Cancer
05/12
05/12
2006-001839-21: A Randomized Phase IIb Study With Biomarker Evaluation (Cherlob) To Evaluate The Activity Of Different Combinations Of Lapatinib With Other Pre-Surgery Chemotherapy In Her2 Positive Operable Breast Cancer

Completed
2
120
Europe, RoW
Lapatinib, Trastuzumab, Paclitaxel, Fluorouracil, Epidoxorubicin, Cyclophosphamide, Methothrexate, GW572016, Film-coated tablet, Powder for solution for infusion, Concentrate for solution for infusion, Solution for infusion, Tyverb, Herceptin
GLAXO SMITH KLINE, GlaxoSmithKline Research and Development Limited, GlaxoSmithKline Reseacrh and Development Limited, , GSK R&D
HER2+ Primary Breast Cancer, Breast Cancer, Diseases [C] - Cancer [C04]
 
 
NCT00246753: Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy

Completed
2
29
US
lapatinib ditosylate, GW572016
UNC Lineberger Comprehensive Cancer Center, GlaxoSmithKline
Prostate Cancer
07/12
05/13
VITAL, NCT01013740: Lapatinib in Combination With Vinorelbine

Checkmark In combination with vinorelbine in women with ErbB2+ve mBC
Jan 2014 - Jan 2014: In combination with vinorelbine in women with ErbB2+ve mBC
Checkmark ASCO 2013
May 2013 - May 2013: ASCO 2013
Checkmark P2 trial design-SABCS
More
Completed
2
112
Europe, RoW
Vinorelbine, Lapatinib, Capecitabine
Novartis Pharmaceuticals
Cancer
08/12
03/16
NCT00973739: Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors

Checkmark P2 data
Jul 2012 - Jul 2012: P2 data
Completed
2
21
US
Lapatinib, Tykerb
NYU Langone Health, GlaxoSmithKline
Neurofibromatosis 2, Vestibular Schwannoma
10/12
11/12
NCT01118975: GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers

Checkmark P2 data-SABCS
Dec 2011 - Dec 2011: P2 data-SABCS
Terminated
2
12
US
Vorinostat, Zolinza, Lapatinib, Tykerb
University of Maryland, Baltimore, University of Maryland Greenebaum Cancer Center
Breast Cancer, Neoplasm Metastasis
10/12
10/12
NCT00881621: Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer

Checkmark Data ASCO
Jun 2012 - Jun 2012: Data ASCO
Terminated
2
17
US
Lapatinib and Capecitabine, Tykerb, GW572016
Georgetown University, GlaxoSmithKline
Pancreas Cancer
12/12
06/13
NCT00490061: Lapatinib and Radiation for Stage III-IV Head and Neck Cancer Patients Who Cannot Tolerate Concurrent Chemotherapy

Terminated
2
17
US
Lapatinib, Tykerb/Tyverb, GlaxoSmithKline, Radiotherapy (radiation), IMRT - Intensity Modulated Radiotherapy, G.E. Healthcare 1.5T MR, systems revision 12.0 M5, G.E. Healthcare MRI Device and Software, DCE-MRI, Dynamic contrast-enhanced magnetic resonance imaging
Quynh-Thu Le, GlaxoSmithKline
Head and Neck Cancer, Carcinoma, Squamous Cell, Head and Neck Cancers
01/13
06/16
NCT01272141: A Study of Lapatinib in Combination With Everolimus in Patients With Advanced, Triple Negative Breast Cancer

Terminated
2
5
US
Lapatinib and Everolimus, Lapatinib, Tykerb, Everolimus, Affinitor
Emory University
Breast Neoplasms, Breast Cancer, Cancer of the Breast
01/13
01/14
GastroLap, NCT01145404 / 2009-009894-88: Trial of Lapatinib Versus Lapatinib With Capecitabine in Her2+ Metastatic Gastro-Esophageal Cancer

Checkmark ASCO-GI 2015
Jan 2015 - Jan 2015: ASCO-GI 2015
Terminated
2
76
Europe
Lapatinib, Tyverb, Lapatinib plus capecitabine, Tyverb, Xeloda
National Center for Tumor Diseases, Heidelberg
GastroEsophageal Cancer
02/13
10/13
NCT00103194: Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

Completed
2
49
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI)
Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
06/13
06/13
NCT02154373: Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer

Completed
2
50
US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, laboratory biomarker analysis
National Cancer Institute (NCI)
Recurrent Prostate Cancer, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
06/13
06/13
NCT01382706: Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder

Terminated
2
15
US
docetaxel, RP 56976, Taxotere, TXT, lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, immunohistochemistry staining method, immunohistochemistry, fluorescence in situ hybridization, fluorescence in situ hybridization (FISH), laboratory biomarker analysis
University of Southern California, National Cancer Institute (NCI), GlaxoSmithKline
Recurrent Bladder Cancer, Stage III Bladder Cancer, Stage IV Bladder Cancer, Transitional Cell Carcinoma of the Bladder
07/13
12/17
NCT01123473 / 2009-011580-36: Epirubicin Hydrochloride, Cisplatin, and Fluorouracil or Capecitabine With or Without Lapatinib Ditosylate as First-Line Therapy in Treating Patients With Stomach Cancer or Gastroesophageal Junction Cancer

Checkmark P2 trial design - ASCO
Jun 2012 - Jun 2012: P2 trial design - ASCO
Terminated
2
29
Europe
capecitabine, cisplatin, epirubicin hydrochloride, fluorouracil, lapatinib ditosylate
European Organisation for Research and Treatment of Cancer - EORTC
Adenocarcinoma of the Gastroesophageal Junction, Gastric Cancer
08/13
09/14
NCT00756470: Phase II Neoadjuvant in Inflammatory Breast Cancer

Terminated
2
15
US
Lapatinib, Tykerb, GW572016, Paclitaxel, Taxol, 5-Fluorouracil (5-FU), 5-FU, Adrucil, Efudex, Epirubicin, Cyclophosphamide, Cytoxan, Neosar
M.D. Anderson Cancer Center, GlaxoSmithKline
Breast Cancer
10/13
10/13
NCT00769470: Docetaxel, Carboplatin, and Trastuzumab and/or Lapatinib in Treating Women With Stage I, Stage II, or Stage III Breast Cancer That Can Be Removed by Surgery

Checkmark SABCS 2013
Jan 2014 - Jan 2014: SABCS 2013
Completed
2
18
US
trastuzumab, carboplatin, docetaxel, lapatinib ditosylate
Translational Oncology Research International, National Cancer Institute (NCI), University of California, Los Angeles
Breast Cancer
11/13
 
NCT01666431: Single-center Investigator Initiated Pilot Study Investigating the Tumor Response of Squamous Cell Carcinoma Lesions in Patients Under Lapatinib Treatment

Terminated
2
10
Europe
Lapatinib
University of Zurich
Squamous Cell Carcinoma
11/13
11/13
NCT01264081: Lapatinib in Stage IV Melanoma With ERBB4 Mutations

Terminated
2
34
US
Lapatinib
National Cancer Institute (NCI)
Malignant Melanoma
11/13
11/13
2009-012706-39: Multicentric, open-label, single-arm phase II study with oral lapatinib in combination with oral capecitabine plus intrathecally administered liposomal cytarabine (DepoCyte®) for the treatment of meningeal metastasis or meningeal metastasis plus brain metastases in HER2-positive breast-cancer patients

Completed
2
34
Europe
Suspension for injection, Film-coated tablet, DepoCyte, Tyverb, Xeloda
Klinikum der Otto-von-Guericke Universität Magdeburg
Histologically confirmed breast cancer, overexpressing HER2, that has led to neoplastic meningitis.
 
 
NCT00470704: Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer

Checkmark ASCO 2014
May 2014 - May 2014: ASCO 2014
Checkmark P2 data-SABCS
Dec 2011 - Dec 2011: P2 data-SABCS
Active, not recruiting
2
87
US
Lapatinib, Tykerb, Herceptin, trastuzumab
Nancy Lin, MD, GlaxoSmithKline, Novartis
Breast Cancer
11/13
12/24
NCT01477060 / 2011-000155-16: Modulation of Response to Hormonal Therapy With Lapatinib and/or Metformin in Patients With Metastatic Breast Cancer

Terminated
2
32
Europe
Lapatinib, Metformin
Fondazione Michelangelo
Metastatic Breast Cancer
12/13
12/13
NCT01688609: Lapatinib Ditosylate, Trastuzumab, Paclitaxel, and Surgery in Treating Patients With Breast Cancer

Completed
2
18
Japan, US
lapatinib ditosylate, GSK572016, GW-572016, GW2016, Lapatinib, Tykerb, paclitaxel, Anzatax, Asotax, TAX, Taxol, trastuzumab, anti-c-erB-2, Herceptin, MOAB HER2, therapeutic conventional surgery, pharmacological study, pharmacological studies, laboratory biomarker analysis
National Cancer Institute (NCI)
HER2-positive Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
12/13
08/16
NCT01138046: Phase I/II Study of Lapatinib in Combination With Paclitaxel as 1L Chemotherapy for ErbB2-positive MBC

Completed
2
12
Japan
Lapatinib in combination with weekly paclitaxel
GlaxoSmithKline
Neoplasms, Breast
01/14
01/14
NCT00684983: Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer

Checkmark ASCO 2014
May 2014 - May 2014: ASCO 2014
Completed
2
64
US
Capecitabine, Ro 09-1978/000, Xeloda, Cixutumumab, Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12, IMC-A12, Lapatinib Ditosylate, Tykerb, Quality-of-Life Assessment, Quality of Life Assessment
National Cancer Institute (NCI), Southwest Oncology Group
HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7
01/14
10/19
 

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