Home > Result Summaries: Compounds > lapatinib Result Summaries: lapatinib GSKStudy ID Phase Title Summary (Download) 100151 phase 3 A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer (5 citation(s)) 100151_1 Phase 3 A Phase III, Randomized, Open-Label, Multicenter Study Comparing GW572016 and Capecitabine (Xeloda)versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer (15 November 2005 Data Cut-off) (1 citation(s)) 100262 Phase 1 A Phase I, Open-Label, Multicentre, Dose-escalation Study of Oral GW572016 in Combination with Radiation Therapy and Cisplatin in Patients with Stage III-IV Squamous Cell Carcinoma of the Head and Neck (1 citation(s)) 102587 Phase 1 A Single-Dose, Open-Label, Randomized, Three-Way Cross-Over Study in Healthy Subjects to Evaluate the Relative Bioequivalence of Two New Small Tablet Formulations of Lapatinib (GW572016) (0 citation(s)) 104578 phase 3 A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer (0 citation(s)) 105594 phase 2 A phase II open label, multicenter study to evaluate the efficacy and safety of daily dose of Lapatinib in advanced breast cancer patients with HER-2 non-amplified primary tumours and HER-2 positive circulating tumour cells or EGFR positive circulating tumor cells (1 citation(s)) 107671 phase 2 Study EGF107671 – a Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy (1 citation(s)) 108919 phase 3 A RANDOMIZED, OPEN-LABEL, PHASE III STUDY OF TAXANE BASED CHEMOTHERAPY WITH LAPATINIB OR TRASTUZUMAB AS FIRST-LINE THERAPY FOR WOMEN WITH HER2/neu POSITIVE METASTATIC BREAST CANCER (0 citation(s)) 109275 phase 1 An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer (0 citation(s)) 109749 phase 2 Clinical Evaluation of Lapatinib Administered with Capecitabine in Japanese Patients with ErbB2 overexpressing Advanced or Metastatic Breast Cancer (0 citation(s)) 111438 phase 3 A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib plus Capecitabine versus Trastuzumab plus Capecitabine in Patients with Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer (0 citation(s)) 111582 phase 1 An Open Label Study to Examine the Effects of Low-Fat and High-Fat Meals on the Pharmacokinetics of Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients (0 citation(s)) 112564 phase 2 A Multicenter, Open-Label, Phase II Study of lapatinib in Combination with Vinorelbine in Subjects with ErbB2 Amplified Recurrent and Metastatic Breast Cancer (0 citation(s)) 112620 phase 2 A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination with Vinorelbine or Capecitabine in Women with ErbB2 Overexpressing Metastatic Breast Cancer (0 citation(s)) 112883 Cohort study to document background rates of hypertension and Liver Function Test (LFT) elevations in users of Tyrosine Kinase inhibiting drugs-Varian Oncology Database (1 citation(s)) 112930 phase 1 An open-label, randomized, adaptive design, two-period crossover study in cancer patients to evaluate the bioequivalence of alternative formulations of lapatinib compared to the commercial tablet (0 citation(s)) 113153 n\a Liver Function Test (LFT) elevations in cancer patients and users of tyrosine kinase inhibitor (TKI) drugs using the LabRx Database (0 citation(s)) 113349 n\a Breast cancer with over-expression of erbB2 study of the treatment paradigm in metastasis to BRAIN (BRAINSTORM) (1 citation(s)) 113893 n\a PGx132 lapatinib diarrhea pharmacogenetics in EGF10009, EGF100151, EGF10021, EGF10023, EGF102580, EGF102980, EGF103009, EGF104900, EGF105084, EGF105764, EGF20009, EGF20014, EGF30001 and VEG20007 (0 citation(s)) 113896 n\a PGx275 lapatinib liver safety pharmacogenetics in EGF30008 (3 citation(s)) 113960 phase 4 Clinical Outcomes on ErbB2+ MBC patients treated with Lapatinib-Capecitabine after Trastuzumab Progression: Role of early versus late switch to Lapatinib-Capecitabine (TYCO1) - Brazil (0 citation(s)) 114471 n\a PGx320 Tykerb TEACH EGF105485 liver safety pharmacogenetics (0 citation(s)) 115159 n\a PGx349 Exploratory pharmacogenetic analysis of lapatinib hepatotoxicity data – association analyses, genetic signal refinement, and HLA imputation analyses (0 citation(s)) 115270 n\a Assessment of physician compliance to recommended liver function test monitoring for Tykerb patients (0 citation(s)) 115730 n\a PGx423 Pharmacogenetic evaluation of efficacy of lapatinib in EGF104900, EGF20009, EGF105084 and VEG20007 (0 citation(s)) 116294 n\a PGx419: Pharmacogenetic Evaluation of Decrease in Left Ventricular Ejection Fraction (LVEF) in Lapatinib Treated Metastatic Breast Cancer (MBC) Subjects (0 citation(s)) 116548 n\a Retrospective Study of the Prevalence, Predictors, and Consequences of Non-Adherence with Lapatinib in Women with Metastatic Breast Cancer Who Were Previously Treated with Trastuzumab (0 citation(s)) 116805 n\a Indirect comparison lapatinib+capecitabine vs trastuzumab+capecitabine in metastic breast cancer (0 citation(s)) 116911 n\a Indirect Treatment Comparison to Inform the Evaluation of the Cost-Effectiveness of Lapatinib plus Letrozole for First-Line Treatment of Post-Menopausal Women with Hormone Receptor Positive and HER-2 Positive Metastatic Breast Cancer from Canadian Societal and Healthcare System Perspectives (0 citation(s)) 117004 n\a Systematic review and indirect comparison of first line treatments for Human Epidermal Growth Factor Receptor 2 positive (HER2+) advanced or metastatic breast cancer (0 citation(s)) 117394 n\a Exploratory PGx Analysis of ALT elevation in EGF105485 (0 citation(s)) EGF 20002 phase 2 An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects with Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens (1 citation(s)) EGF10001 Phase 1 A Double Blind, Randomized, Placebo-Controlled, Crossover Study To Investigate The Safety, Tolerability And Pharmacokinetics Of Single Oral Escalating Doses Of GW572016 Ditosylate Monohydrate (Lapatinib) In Healthy Volunteers (0 citation(s)) EGF10002 Phase 1 A Double-Blind, Placebo Controlled, Parallel Study To Investigate The Safety, Tolerability, and Pharmacokinetics of Multiple Oral GW572016 (Lapatinib) Doses In Healthy Subjects (0 citation(s)) EGF10003 Phase 1 A Phase I, Open-Label, Multiple Dose, Dose-Escalation Study of GW572016 in Patients with Solid Tumors (4 citation(s)) EGF10004 Phase 1 An Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study of Multiple Doses of GW572016 toExamine the Inhibition of ErbB1 (EGFR)/ErbB2 Phosphorylation in Cancer Patients with Solid Tumors (5 citation(s)) EGF10005 Phase 1 A Phase I, Open-Label Pharmacokinetic Study of the Safety and Tolerability of GW572016 Daily in Combination with Capecitabine on a Three Week Schedule in Patients with Solid Tumors (0 citation(s)) EGF10008 Phase 1 A Single Dose, Open Label, Randomized, Five-way, Crossover Study in Healthy Subjects to Evaluate the Effect of Food on the Pharmacokinetics of GW572016 and to Evaluate the Relative Bioavailability of GW572016 as a Salt (F) versus Base (X) and Capsule (F) versus Tablet (F) (0 citation(s)) EGF10009 Phase 1 A Phase I, Open-Label, Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 in Combination with Paclitaxel in Patients with Solid Tumors (0 citation(s)) EGF10010 Phase 1 A Phase I, Open-Label, Pharmacokinetic Study of the Safety and Tolerability of GW572016 (Lapatinib) in Combination with Oxaliplatin/Fluorouracil/Leucovorin (0 citation(s)) EGF10011 Phase 1 A Phase I, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 (lapatinib) in Combination with Irinotecan and 5-Fluorouracil/Leucovorin (0 citation(s)) EGF10012 Phase 1 A Phase I, Open-Label, 4-Period, Crossover Study in Healthy Subjects to Evaluate the Bioequivalence of 2 Oral Tablet Formulations of GW572016 Ditosylate Monohydrate (Lapatinib) (0 citation(s)) EGF10013 Phase 1 An open-label, two-way randomized crossover study to evaluate the potential inhibition of GW572016 metabolism by ketoconazole (0 citation(s)) EGF10014 Phase 1 An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of a Single 100mg Oral Dose of Lapatinib in Healthy Subjects and in Subjects with Hepatic Impairment (0 citation(s)) EGF10015 Phase 1 A Four-Way Cross-Over Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally and Intravenously Administered Midazolam in Cancer Patients (0 citation(s)) EGF100161 phase 1 An open-label, multicenter, Phase I/II dose escalation study of oral GW572016 in combination with docetaxel (Taxotere) plus trastuzumab (Herceptin) in subjects previously untreated for ErbB2-overexpressing metastatic breast cancer (0 citation(s)) EGF10018 phase 1 An open-label, fixed sequence, two period study to evaluate the potential induction of GW572016 metabolism by carbamazepine. (0 citation(s)) EGF10019 Phase 1 An open-label, non-randomized, mass balance study to characterize the metabolism of isotopically labelled GW572016 after a single 250 mg oral suspension dose of [14C]- GW572016 in healthy subjects (0 citation(s)) EGF10020 Phase 1 Phase I Study of GW572016 in Patients with Solid Tumors <Clinical Pharmacology Study> (1 citation(s)) EGF10021 Phase 1 A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination with docetaxel (TAXOTERE) (0 citation(s)) EGF10023 Phase 1 A Phase I, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 (lapatinib) in Combination with Trastuzumab (Herceptin®) (0 citation(s)) EGF10024 Phase 1 A Phase I, Open Label, Randomized, Four-way, Crossover Study in Healthy Subjects to Evaluate the Relative Bioavailability of Three Batches of Oral GW572016 Tablets with Varying Dissolution Rates Compared to Oral GW572016 as a Suspension (0 citation(s)) EGF10027 phase 1 A Phase I, Open Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of GW572016 in Once Daily Versus Twice Daily Dosing Regimens in Patients with Treatment- Naive Breast Cancer (0 citation(s)) EGF10030 Phase 1 A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination with Letrozole (Femara®) in Cancer Subjects (0 citation(s)) EGF10032 Phase 1 A Phase I, Open-Label, Three-Period, Randomized, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of GW572016 in Cancer Patients with a Continuation Phase to Evaluate the Safety of GW572016 Administered Once Daily. (1 citation(s)) EGF100642 phase 1 Phase II Clinical Study of GW572016 in Patients with Advanced or Metastatic Breast Cancer (0 citation(s)) EGF102580 phase 2 A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination with Paclitaxel as Neoadjuvant Therapy in Patients with Newly Diagnosed Inflammatory Breast Cancer (1 citation(s)) EGF102980 Phase 2 A Phase II, Open-Label Study Evaluating Clinical Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of Lapatinib (GW572016) in Patients with Relapsed Adenocarcinoma of the Esophagus, including Tumors of the Gastroesophageal Junction and Gastric Cardia (0 citation(s)) EGF103009 phase 2 A Phase II Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Lapatinib in Patients with Relapsed or Refractory Inflammatory Breast Cancer (2 citation(s)) EGF103890 phase 2 A Phase II, Open-Label Study of the Clinical Activity, Safety, and Tolerability of Lapatinib in Combination with Bevacizumab in Subjects with Advanced or Metastatic ErbB2-Overexpressing Breast Cancer (1 citation(s)) EGF103892 phase 1 A Phase I Dose Escalation Study of the Safety and Tolerability of Lapatinib in Combination with Carboplatin, Paclitaxel, and Herceptin in Patients with Metastatic Breast Cancer (0 citation(s)) EGF104334 Phase 2 A Randomized, Single Blinded, Placebo-controlled, Multi-centre, Phase II Study of Lapatinib in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (0 citation(s)) EGF104383 phase 3 A Randomized, Double Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing the Activity of Paclitaxel Plus Trastuzumab Plus Lapatinib to Paclitaxel Plus Trastuzumab Plus Placebo in Women with ErbB2 Overexpressing Metastatic Breast Cancer (1 citation(s)) EGF104535 phase 3 A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase III Study of Lapatinib (GW572016) in Combination with Paclitaxel versus Paclitaxel plus Placebo in Subjects with ErbB2 Amplified Metastatic Breast Cancer (0 citation(s)) EGF104900 phase 3 A Randomized, Multicenter, Open-Label, Phase III Study of Lapatinib in Combination with Trastuzumab versus Lapatinib Monotherapy in Subjects with HER2-positive Metastatic Breast Cancer whose disease has progressed on Trastuzumab-Containing Regimens (2 citation(s)) EGF104911 phase 2 Phase II Clinical Study of lapatinib (GW572016) in Patients with ErbB2 Over - Expressing Advanced or Metastatic Breast Cancer (1 citation(s)) EGF105084 phase 2 A Phase II Study of Lapatinib for Brain Metastases in Subjects with ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy (1 citation(s)) EGF105485 phase 3 A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women with Early-Stage ErbB2 Overexpressing Breast Cancer (0 citation(s)) EGF105635 phase 1 Phase I/II Clinical Study of GW572016 (Lapatinib Ditosylate Monohydrate) in Combination with Trastuzumab in Patients with Breast Cancer Previously Treated with Trastuzumab (0 citation(s)) EGF105764 phase 2 An open-label, single-arm, multi-centre, Phase II study of oral lapatinib in combination with paclitaxel as first-line treatment for ErbB2-amplified metastatic breast cancer patients (2 citation(s)) EGF105884 phase 2 A Randomized, double-blind, placebo controlled, multicentre, phase II study of oral lapatinib in combination with concurrent radiotherapy and cisplatin versus radiotherapy and cisplatin alone, in subjects with stage III, IVA, B squamous cell carcinoma of the head and neck (SCCHN) (1 citation(s)) EGF106903 phase 3 Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study: A randomised, multicenter open-label phase III study of neoadjuvant lapatinib, trastuzumab and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer (1 citation(s)) EGF106988 phase 2 Chemotherapy plus lapatinib or trastuzumab or both in Her2+ primary breast cancer. A randomized phase IIb study with biomarker evaluation. (1 citation(s)) EGF107692 phase 2 Letrozole versus Letrozole plus Lapatinib (GW572016) in hormone-sensitive, HER-2 negative operable breast cancer. A double blind randomized Phase II study with biomarker evaluation. (0 citation(s)) EGF108916 phase 2 An open-label, multi-centre study of lapatinib in combination with chemotherapy in patients with ErbB2 over expressing breast cancer after trastuzumab failure in the neoadjuvant or adjuvant setting (1 citation(s)) EGF108991 phase 1 A Phase I/II Study of Lapatinib in Combination with Oxaliplatin and Capecitabine in Subjects with Advanced or Metastatic Colorectal Cancer (0 citation(s)) EGF109462 phase 1 A single-arm, two-stage Phase II study of Lapatinib and Pemetrexed in the second line treatment of advanced or metastatic Non-Small Cell Lung Cancer (1 citation(s)) EGF109491 phase 3 An Open-Label Multicenter study Administering Lapatinib and Capecitabine in Women with Advanced or MEtastatic Breast Cancer (1 citation(s)) EGF110557 phase 1 An Open-Label, Two-Part, Single Sequence Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally Administered Digoxin in Subjects with Metastatic ErbB2 Positive Breast Cancer (0 citation(s)) EGF19060 phase 1 An Open Label, Phase 1b Rollover Study to Assess the Long-Term Safety Profile of Lapatinib (GW572016) in Cancer Patients. (0 citation(s)) EGF20001 phase 2 A parallel-arm, multi-center, open-label randomized phase II study of orally administered GW572016 as single-agentsecond-line treatment of patients with locally advanced or metastatic renal cell carcinoma (0 citation(s)) EGF20003 Phase 2 A single-arm, multi-centre, open-label phase II study of orally administered GW572016 as single-agent second-line treatment of patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract (1 citation(s)) EGF20004 Phase 2 An Open-Label, Multicenter, Phase II Study of Oral Lapatinib (GW572016) as Single Agent, Second-Line Therapy in Subjects with Metastatic Colorectal Cancer Who Have Progressed on First-Line Therapy with 5-Fluorouracil in Combination with Irinotecan or Oxaliplatin (0 citation(s)) EGF20008 phase 2 An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects with Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving HERCEPTIN-Containing Regimens (0 citation(s)) EGF20009 phase 2 A Phase II, Open-Label, Randomized, Parallel-Group Multicenter Trial Comparing Two Schedules of GW572016 as First-Line Monotherapy in Patients with Advanced or Metastatic Breast Cancer (1 citation(s)) EGF20014 phase 2 A Phase 2 Multicenter Trial Comparing Two Schedules of GW572016 as First or Second Line Monotherapy in Subjects with Advanced or Metastatic Non-Small Cell Lung Cancer with either Bronchioloalveolar Carcinoma or No Smoking History (2 citation(s)) EGF30001 phase 3 A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination with Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer (1 citation(s)) EGF30008 phase 3 A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing GW572016 and Letrozole versus Letrozole in Subjects with Estrogen/Progesterone Receptor-Positive Advanced or Metastatic Breast Cancer (2 citation(s)) LPT108741 phase 2 A Phase II, Placebo Controlled, Double-Blind, Randomized, Discontinuation Study of Lapatinib Administered Orally to Subjects with ErbB2 Positive Ovarian, Gastric/Esophageal Adenocarcinoma, Uterine Serous Papillary, or Bladder Cancer (1 citation(s)) LPT109096 phase 2 Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women with ErbB2- (HER2/neu-) Overexpressing Invasive Breast Cancer (0 citation(s)) LPT109747 phase 2 An exploratory, phase II trial to determine the association of lapatinib induced fluoropyrimidine gene changes with efficacy parameters of lapatinib and capecitabine in first line gastric cancer (0 citation(s)) LPT111110 phase 2 A Phase II, Single-Arm, Multi-Center Study Evaluating the Combination of Vinorelbine and Lapatinib in Women with ErbB2 Overexpressing Metastatic Breast Cancer (0 citation(s)) LPT111111 phase 2 LPT 111111- A Single-arm, Multicenter Phase II Study to Evaluate The Combination of Weekly Nanoparticle Albumin bound Paclitaxel (nab-Paclitaxel or ABRAXANE®) and Lapatinib (TYKERB®) in Women With No More Than One Prior Treatment for ErbB2 Overexpressing Metastatic Breast Cancer (1 citation(s)) VEG108838 phase 2 A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib versus Lapatinib Monotherapy in Patients with ErbB2 over-expressing Inflammatory Breast Cancer (2 citation(s)) VEG20007 phase 2 A Phase II, Open-Label, Randomized, Multicenter Trial of GW786034 (Pazopanib) in Combination with Lapatinib (GW572016) Compared to Lapatinib Alone as First Line Therapy in Subjects with Advanced or Metastatic Breast Cancer with ErbB2 Fluorescence In Situ Hybridization (FISH) Positive Tumors (1 citation(s))
