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Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073 - Screening

- 10/13/20 - 1 form, 24 itemgroups, 273 items, 1 language
Itemgroups: Date of visit, Assessment Date, Trial Screening, Enrollment, Clinical Trial Subject Unique Identifier, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, disease characteristic, disease characteristic, Neoplasm Metastasis, Electrocardiography, Echocardiography; Multiple gated acquisition scanning, Laboratory Procedures, Central Laboratory; Laboratory Procedures, Local, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Central Laboratory, Data, Disease, Operative Surgical Procedures, Disease, Relationships, Disease, Clinical Trials, Therapeutic procedures, Relationships, Disease, Cancer treatment, Prior Therapy, Neurologic Examination, Vital signs, Prior Radiation Therapy, Prior Radiation Therapy, Central Nervous System
Study ID: 107671 Clinical Study ID: 107671 Study Title: EGF107671 – A Phase II Study of Lapatinib plus Topotecan or Lapatinib plus Capecitabine in the Treatment of Recurrent Brain Metastases from ErbB2-Positive Breast Cancer Following Cranial Radiotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00437073 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: N/A Trade Name: capecitabine, topotecan, lapatinib Study Indication: Neoplasms, Breast; Recurrent Brain Metastases

Effects of Esomeprazole on Lapatinib in Subjects with Breast Cancer; 109275 - Screen

- 9/17/21 - 1 form, 19 itemgroups, 296 items, 1 language
Itemgroups: Screening procedure, Enrollment, Date of visit, Demography, Eligibility Determination, Inclusion, Exclusion Criteria, Echocardiography, Multiple gated acquisition scanning, Disease, Disease Characteristic, cancer treatment, Prior Therapy, Therapeutic radiology procedure, cancer treatment, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Randomisation, Numbers, Laboratory Procedures, Chemistry, Clinical, Laboratory Procedures, Hematology finding, Clinical Trial Subject Unique Identifier
Study ID: 109275 Clinical Study ID: 109275 Study Title: An Open-Label, Single Sequence Study to Examine the Effects of Esomeprazole on the Pharmacokinetics of Orally Administered Lapatinib in Subjects with Metastatic ErbB2 Positive Breast Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Lapatinib, Esomeprazole Trade Name: lapatinib plus esomeprazole Study Indication: Neoplasms, Breast

XELODA and Lapatinib Advanced or Metastatic Breast Cancer Screening NCT00078572

- 9/20/21 - 1 form, 11 itemgroups, 122 items, 1 language
Itemgroups: Pharmacogenetic Research - Blood - Informed Consent, Pharmacogenetic Research - Tumor - Informed Consent, Inclusion Criteria Worksheet, Exclusion Criteria Worksheet, Inclusion and Exclusion Criteria, Current Medical Conditions / Baseline Signs and Symptoms, Physical Exam (Vital Signs, Weight, Height), ECOG Performance Status, Cardiac Assessments Screening, Hematology, Clinical Chemistry
XELODA and Lapatinib Advanced or Metastatic Breast Cancer Study ID: 100151 Clinical Study ID: EGF100151 Study Title: A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) versus Capecitabine in Women with Refractory Advanced or Metastatic Breast Cancer Clinicaltrials.gov Identifier: NCT00078572 https://clinicaltrials.gov/ct2/show/NCT00078572 Procedure: Screening Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Breast Cancer; Neoplasms, Breast

GSK Dose proportionality of fluticasone furoate and equivalence of vilanterol in healthy adults NCT01213849 - Screening

- 4/16/18 - 1 form, 12 itemgroups, 88 items, 1 language
Itemgroups: Demography, Vital Signs, Medical History, History of Tobacco Use, Drug and Alcohol Screen, Local Laboratory - Haematology, Local Laboratory - Clinical Chemistry, Urinalysis, Serology - HIV Screen, 12-lead ECG, Eligibility Question, Randomisation
Study ID: 102932 Clinical Study ID: HZA102932 Study Title:An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01213849 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma Documentation part: Screening

Betamethasone pharmacokinetics of a co-administered infusion of GSK221149A; 105036 - Inform Screening (Screen)

- 8/28/19 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Screening procedure
Study ID: 105036 Clinical Study ID: 105036 Study Title: A single-blind, randomized, placebo-controlled study to investigate the safety, tolerability, and potential effects on betamethasone pharmacokinetics of a co-administered infusion of GSK221149A in healthy female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: betamethasone Trade Name: Retosiban Study Indication: Women's Health & Pregnancy - Other, pre-term labour

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Screen

- 7/12/19 - 1 form, 20 itemgroups, 101 items, 1 language
Itemgroups: Administrative documentation, Demography, Vital Signs, Ovarian Carcinoma, Prior Therapy, Drug toxicity, Current Medical Status, Due to, Malignant Neoplasms, Disease, Current, Ovarian carcinoma, Disease characteristic, Laboratory Procedures, CA-125 Antigen, Operative Surgical Procedure, Previous, Related to Cancer, Cancer Treatment, Previous, Lesion, Indicator, Evaluation, Non-Measurable Lesion, Evaluation, Therapeutic procedure, Therapeutic regimen, Eligibility Determination, Inclusion, Eligibility Determination, Inclusion, Exclusion Criteria, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

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