ID
40267
Description
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 prior Anti-Cancer procedures. It has to be filled in for screening.
Link
https://clinicaltrials.gov/ct2/show/NCT00821054
Keywords
Versions (2)
- 3/26/20 3/26/20 - Christian Arras
- 3/26/20 3/26/20 - Christian Arras
Copyright Holder
GlaxoSmithKline
Uploaded on
March 26, 2020
DOI
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License
Creative Commons BY-NC 4.0
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Effects of Low-fat and high-fat meals on the Pharmacokinetics of Lapatinib in ErB2+ Breast Cancer patients, NCT00821054
Prior Anti-Cancer procedures
- StudyEvent: ODM
Description
Prior Anti-Cancer Therapy: Chemotherapy, Hormonal, Immunotherapy, Biological Therapy
Alias
- UMLS CUI-1
- C0920425
- UMLS CUI-2
- C1514463
- UMLS CUI-3
- C0392920
- UMLS CUI-4
- C0279025
- UMLS CUI-5
- C1531518
- UMLS CUI-6
- C0021083
Description
If Yes, specify below
Data type
text
Alias
- UMLS CUI [1,1]
- C0920425
- UMLS CUI [1,2]
- C1514463
Description
hidden/not required
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
Trade name preferred
Data type
text
Alias
- UMLS CUI [1]
- C2360065
Description
hidden/not required,
Data type
text
Alias
- UMLS CUI [1]
- C2826923
Description
hidden/not required
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Description
hidden/not required
Data type
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Description
hidden/not required
Data type
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Description
Treatment protocol, number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0040808
- UMLS CUI [1,2]
- C0237753
Description
Therapy type, cancer treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0920425
Description
Number of Cycles, Dosage count
Data type
integer
Alias
- UMLS CUI [1]
- C2045831
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0750480
Description
Units
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Primary Intent, cancer treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C1283828
- UMLS CUI [1,2]
- C0205225
- UMLS CUI [1,3]
- C0920425
Description
Start Date
Data type
partialDate
Alias
- UMLS CUI [1]
- C0808070
Description
End Date
Data type
partialDate
Alias
- UMLS CUI [1]
- C0806020
Description
hidden/not required
Data type
text
Alias
- UMLS CUI [1]
- C0920425
Description
Prior Anti-Cancer Therapy: Radiotherapy
Alias
- UMLS CUI-1
- C0279134
- UMLS CUI-2
- C0920425
Description
If yes, please specify below:
Data type
text
Alias
- UMLS CUI [1]
- C0279134
Description
hidden/not required
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
irradiation site
Data type
text
Alias
- UMLS CUI [1]
- C2169202
Description
Primary Intent, cancer treatment
Data type
text
Alias
- UMLS CUI [1,1]
- C1283828
- UMLS CUI [1,2]
- C0205225
- UMLS CUI [1,3]
- C0920425
Description
Start Date
Data type
partialDate
Alias
- UMLS CUI [1]
- C0808070
Description
End Date
Data type
partialDate
Alias
- UMLS CUI [1]
- C0806020
Description
This will be a hidden Item populated by a rule
Data type
text
Alias
- UMLS CUI [1]
- C0920425
Description
Prior anti-cancer medical/surgical procedures
Alias
- UMLS CUI-1
- C1948041
- UMLS CUI-2
- C0920425
- UMLS CUI-3
- C1514463
Description
If Yes, please specify below:
Data type
text
Alias
- UMLS CUI [1,1]
- C2826292
- UMLS CUI [1,2]
- C1948041
Description
hidden/not required
Data type
text
Alias
- UMLS CUI [1]
- C2348184
Description
Therapeutic Procedure
Data type
text
Alias
- UMLS CUI [1]
- C0087111
Description
Time is optional
Data type
partialDatetime
Alias
- UMLS CUI [1]
- C2584899
Similar models
Prior Anti-Cancer procedures
- StudyEvent: ODM
C1514463 (UMLS CUI-2)
C0392920 (UMLS CUI-3)
C0279025 (UMLS CUI-4)
C1531518 (UMLS CUI-5)
C0021083 (UMLS CUI-6)
C1514463 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0178602 (UMLS CUI [2,1])
C0750480 (UMLS CUI [2,2])
C0205225 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0920425 (UMLS CUI-2)
C0205225 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0920425 (UMLS CUI-2)
C1514463 (UMLS CUI-3)
C1948041 (UMLS CUI [1,2])