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Study ID Status Title Patient Level Data
EGF10002 Completed A Double-Blind, Placebo Controlled, Parallel Study To Investigate The Safety, Tolerability, and Pharmacokinetics of Multiple Oral GW572016 (Lapatinib) Doses In Healthy Subjects
EGF10003 Completed A Phase I, Open-Label, Multiple Dose, Dose-Escalation Study of GW572016 in Patients with Solid Tumors
EGF10004 Completed 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
EGF10005 Completed 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 Completed 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 Completed A Phase I, Open-Label, Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 in Combination with Paclitaxel in Patients with Solid Tumors
EGF10010 Completed A Phase I, Open-Label, Pharmacokinetic Study of the Safety and Tolerability of GW572016 (Lapatinib) in Combination with Oxaliplatin/Fluorouracil/Leucovorin
EGF10011 Completed A Phase I, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 (lapatinib) in Combination with Irinotecan and 5-Fluorouracil/Leucovorin
EGF10012 Completed 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 Completed An open-label, two-way randomized crossover study to evaluate the potential inhibition of GW572016 metabolism by ketoconazole
EGF10014 Completed 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 Completed A Four-Way Cross-Over Study to Examine the Effects of Lapatinib on the Pharmacokinetics of Orally and Intravenously Administered Midazolam in Cancer Patients
EGF100161 Active, Not Recruiting 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
EGF10018 Completed An open-label, fixed sequence, two period study to evaluate the potential induction of GW572016 metabolism by carbamazepine.
EGF10019 Completed 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
EGF10020 Completed Phase I Study of GW572016 in Patients with Solid Tumors <Clinical Pharmacology Study>
EGF10021 Completed A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination with docetaxel (TAXOTERE)
EGF10023 Completed A Phase I, Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of GW572016 (lapatinib) in Combination with Trastuzumab (Herceptin®)
EGF10024 Completed 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
EGF10027 Completed 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
EGF10030 Completed A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination with Letrozole (Femara®) in Cancer Subjects
EGF10032 Completed 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.
EGF100642 Completed Phase II Clinical Study of GW572016 in Patients with Advanced or Metastatic Breast Cancer
EGF102580 Completed 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 Completed 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

 

 

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