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Study ID Status Title Patient Level Data
DB1111509 Completed A single centre, randomised, placebo-controlled, four-way cross over study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705 and GW642444 as monotherapies and in combination in healthy subjects. Study Listed on ClinicalStudyDataRequest.com
DB1111581 Completed A multicenter, randomized, double-blind, placebo-controlled, parallel-group, 4-week study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of repeat inhaled doses of the combination of GSK233705 and GW642444 administered once-daily in subjects with COPD Study Listed on ClinicalStudyDataRequest.com
DIX110434 Completed A Single-Center, Non-Randomized, Open-Label, Comparative Study to Assess the Utility of Novel Technologies and Biomarkers as Methods for Measuring Human Pharmacodynamic Response to 8 Weeks of Administration of Rosiglitazone Maleate 4mg BID in Healthy Normal or Overweight Controls, Healthy Obese Subjects and Subjects with Type 2 Diabetes Mellitus (T2DM) Study Listed on ClinicalStudyDataRequest.com
DPB100925 Completed A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of denagliptin, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension Study Listed on ClinicalStudyDataRequest.com
EFC3557 Completed A multicenter, multinational, randomized, double-blind study to compare the efficacy and safety of fondaparinux sodium (Org31540/SR90107A) with dalteparin (Fragmin) in the prevention of venous thromboembolic events in high-risk abdominal surgery (PEGASUS) Study Listed on ClinicalStudyDataRequest.com
EFC4582 Completed A multicenter, multinational, randomized, double-blind study of fondaparinux sodium (Org31540/SR90107A) versus placebo for the prolonged prevention of VTE in hip fracture surgery. (PENTIHFRA PLUS) Study Listed on ClinicalStudyDataRequest.com
EGF 20002 Completed 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
EGF10001 Completed 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 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)
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
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
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

 

 

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GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.
GSK-sponsored clinical trials are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.

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