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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Lapatinib

- 20/07/20 - 1 modulo, 3 itemgroups, 9 elementi, 1 linguaggio

Itemgroups: Administrative Data, Lapatinib Dosing, Treatment confirmation

Study ID: 111582 Clinical Study ID: 111582 Study Title: 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the Lapatinib Dosing information. It has to be filled in once for each week 1, week 2 and week 3.

Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054 - Lapatinib diary

- 04/07/20 - 1 modulo, 7 itemgroups, 10 elementi, 1 linguaggio

Itemgroups: Administrative Data, Week number and study day, Predose Overnight Fast, Lapatinib Dosage, Count of entities, Postdose Fasting, Post-dose Vomiting, Therapeutic procedure, Confirmation

Study ID: 111582 Clinical Study ID: 111582 Study Title: 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. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00821054 https://clinicaltrials.gov/ct2/show/NCT00821054 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib Trade Name: N/A Study Indication: Neoplasms, Breast The study consists of a screening, four study visits at day-1, week 1, 2 and 3 and a follow-up visit. This document contains the Lapatinib diary. This form is for dosing and meal data from the diary only. Go to visits Week 1 to Week 3 for Lapatinib and Meal data from clinic visits. This form has to be filled in for each week and each study day of the trial.

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