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Study ID Status Title Patient Level Data
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
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
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.
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
EGF102988 Completed A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects with Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)
EGF103009 Completed A Phase II Study to Evaluate the Efficacy, Safety and Pharmacodynamics of Lapatinib in Patients with Relapsed or Refractory Inflammatory Breast Cancer
EGF103890 Active, Not Recruiting 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
EGF104334 Completed 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
EGF104900 Completed 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
EGF105485 Completed A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women with Early-Stage ErbB2 Overexpressing Breast Cancer
EGF105764 Completed 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
EGF105884 Completed 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)
EGF108916 Terminated 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
EGF108991 Completed A Phase I/II Study of Lapatinib in Combination with Oxaliplatin and Capecitabine in Subjects with Advanced or Metastatic Colorectal Cancer
EGF109462 Completed 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

 

 

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