Lapatinib has been approved in the United States

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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lapatinib studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
EGF100151 (data cut off . 03 April 2006) III A Phase III, Randomized, Open-Label, Multicenter Study Comparing GW572016 and Capecitabine (Xeloda) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer (03April2006 Data Cut-off)
EGF100151 (data cut off 15 November 2005 - prespecified interim analysis) III 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)
EGF20001 III A parallel-arm, multi-center, open-label randomized phase II study of orally administered GW572016 as single-agent second-line treatment of patients with locally advanced or metastatic renal cell carcinoma
EGF100262 II 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
EGF102580 II 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
EGF102980 - FINAL II 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
EGF104334 II A Randomized, Single Blinded, Placebo-controlled, Multicentre, Phase II Study of Lapatinib in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck
EGF105084 (Lapatinib Monotherapy) II A Phase II Study of Lapatinib for Brain Metastases in Subjects with ErbB2-Positive Breast Cancer Following Trastuzumab-Based Systemic Therapy and Cranial Radiotherapy
EGF20002 II 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
EGF20003 II 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
EGF20004 II 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
EGF20008 II 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
EGF20009 II A Phase II, Open-Label, Randomized, Parallel-Group Multicentre Trial Comparing Two Schedules of GW572016 as First-Line Monotherapy in Patients with Advanced or Metastatic Breast Cancer
EGF20014 II A phase II 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
EGF10001 I 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
EGF10002 I A Double-Blind, Placebo Controlled, Parallel Study To Investigate The Safety, Tolerability, and Pharmacokinetics of Multiple Oral GW572016 (Lapatinib) Doses In Healthy Subjects
EGF10003 I A Phase I, Open-Label, Multiple Dose, Dose-Escalation Study of GW572016 in Patients with Solid Tumors
EGF10004 I An Open-Label, Safety, Pharmacokinetic and Pharmacodynamic Study of Multiple Doses of GW572016 to Examine the Inhibition of ErbB1 (EGFR)/ErbB2 Phosphorylation in Cancer Patients with Solid Tumors
EGF10005 I 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
EGF10008 I 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)
EGF10009 I A Phase I, Open-Label, Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 in Combination with Paclitaxel in Patients with Solid Tumors
EGF10010 I A Phase I, Open-Label, Pharmacokinetic Study of the Safety and Tolerability of GW572016 (Lapatinib) in Combination with Oxaliplatin/Fluorouracil/Leucovorin
EGF10011 I A Phase I, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 (lapatinib) in Combination with Irinotecan and 5-Fluorouracil/Leucovorin
EGF10012 I 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)
EGF10013 I An open-label, two-way randomized crossover study to evaluate the potential inhibition of GW572016 metabolism by ketoconazole
EGF10014 I 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
EGF10015 I A Four-Way Cross-Over Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally and Intravenously Administered Midazolam in Cancer Patients.
EGF10018 I An open-label, fixed sequence, two period study to evaluate the potential induction of GW572016 metabolism by carbamazepine.
EGF10019 I 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
EGF10021 I A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of Lapatinib in Combination with Docetaxel (Taxotere)
EGF10023 I A Phase I, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 (lapatinib) in Combination with Trastuzumab (Herceptin®)
EGF10024 I 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
EGF10030 I A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination with Letrozole (Femara®) in Cancer Subjects
EGF10032 I 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.
EGF102587 I 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)