Description:

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

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Versions (1)
  1. 10/13/20 10/13/20 -
Copyright Holder:
GlaxoSmithKline
Uploaded on:

October 13, 2020

DOI:
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License :
Creative Commons BY 4.0
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Lapatinib + Topotecan or + Capecitabine in Recurrent Brain Metastases from Breast Cancer; NCT00437073

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Details

Cycle 1 - Day 1

1 forms  
  1. StudyEvent: ODM
    1. Cycle 1 - Day 1
Date of Visit/Assessment
Prior Visit Prompt
Is the visit date for start of this new cycle occurring on the same date as the Day 1 Pre-dose visit for a new subject, or an End of Cycle assessment at Week 4 or Week 8 for an ongoing subject? If “YES,” then certain assessments do not need to be repeated.
Central/Local Lab
Was a central laboratory used?
Was a local lab used for Chemistry assessments?
Was a local lab used for Hematology assessments?
Local Laboratory - Clinical Chemistry
Laboratory Used For This Sample
ALT
ALT - Results
AST
AST - Results
AST - Low
Total Bilirubin
Glucose
Total Protein
Potassium
Sodium
Sodium - Results
Calcium
Alkaline Phosphatase
Alkaline Phosphatase - Results
BUN
BUN - Results
Urea
Urea - Results
Albumin
Creatinine
Creatinine Clearance
Creatinine Clearance - Units
Creatinine Clearance - High
Local Laboratory - Hematology
Laboratory Used For This Sample
WBC
RBC
RBC - Results
Haemoglobin
Haematocrit
Lymphocytes
Units for Lymphocytes
Monocytes
Monocytes - Results
Units for Monocytes
Eosinophils
Unit of Eosinophils
Basophils
Basophils - Results
Units for Basophils
Platelets
Platelets - Results
Total Neutrophils
Total Neutrophils - Results
Units for Neutrophils
Central Lab Data
Not Done
Not Done
Vital Signs
kg
m2
mmHg
mmHg
bpm
°C
Investigational Product Lapatinib
Investigational Product
mg/m2
mg
Was dose delayed?
Yes, check all that apply
4 more items in the detailed view.
Was dose reduced?
Yes, check all that apply
4 more items in the detailed view.
Investigational Product - IV Topotecan Dosing
Sequence number
Investigational Product
mg/m2
mg
Was dose delayed?
Yes, check all that apply
4 more items in the detailed view.
Other, specify
Was dose reduced?
Yes, check all that apply
4 more items in the detailed view.
Other, specify
Treatment Confirmation
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Lapatinib Compliance
Continue in This Arm?
Will subject continue in current arm?
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