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Informations:
Erreur:
ID
40258
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 tumor type, disease characteristics and metastatic disease characteristics. It has to be filled in for the Screening visit.
Lien
https://clinicaltrials.gov/ct2/show/NCT00821054
Mots-clés
Versions (3)
- 26/03/2020 26/03/2020 - Christian Arras
- 26/03/2020 26/03/2020 - Christian Arras
- 26/03/2020 26/03/2020 - Christian Arras
Détendeur de droits
GlaxoSmithKline
Téléchargé le
26 mars 2020
DOI
Pour une demande vous connecter.
Licence
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
Disease characteristics
- StudyEvent: ODM
Similar models
Disease characteristics
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Date of Visit
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
CL Item
Breast Cancer (B)
CL Item
Other solid tumor malignancy (OT)
Item Group
Disease characteristics
C0599878 (UMLS CUI-1)
C0678222 (UMLS CUI-2)
C0678222 (UMLS CUI-2)
Item
Primary tumor at initial diagnosis
integer
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
CL Item
Breast (6)
Date of initial diagnosis
Item
Date of initial diagnosis
partialDate
C2316983 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,2])
Item
TNM Staging at initial diagnosis, primary tumor
text
C4071762 (UMLS CUI [1,1])
C0475455 (UMLS CUI [1,2])
C0475455 (UMLS CUI [1,2])
Code List
TNM Staging at initial diagnosis, primary tumor
CL Item
T0 (T0)
CL Item
T1 (T1)
CL Item
T1A (T1a)
CL Item
T1B (T1b)
CL Item
T1C (T1c)
CL Item
T2 (T2)
CL Item
T2A (T2a)
CL Item
T2B (T2b)
CL Item
T2C (T2c)
CL Item
T3 (T3)
CL Item
T3A (T3a)
CL Item
T3B (T3b)
CL Item
T3C (T3c)
CL Item
T4 (T4)
CL Item
TIS (TIS)
CL Item
TX (TX)
Item
TNM Stage at initial diagnosis, regional lymph nodes
text
C4071762 (UMLS CUI [1,1])
C0456532 (UMLS CUI [1,2])
C0456532 (UMLS CUI [1,2])
Code List
TNM Stage at initial diagnosis, regional lymph nodes
CL Item
NOI+ (N0i+)
CL Item
N1 (N1)
CL Item
N1MI (N1mi)
CL Item
N2 (N2)
CL Item
N2A (N2A)
CL Item
N2B (N2B)
CL Item
N2C (N2C)
CL Item
N3 (N3)
CL Item
NX (NX)
CL Item
N0 (N0)
Item
TNM Stage at initial diagnosis, distant metastasis
text
C4071762 (UMLS CUI [1,1])
C0456533 (UMLS CUI [1,2])
C0456533 (UMLS CUI [1,2])
Code List
TNM Stage at initial diagnosis, distant metastasis
CL Item
M0 (M0)
CL Item
M1 (M1)
CL Item
MX (MX)
Item
Histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C3172269 (UMLS CUI [1,2])
CL Item
Infiltrating ductal NOS (12)
CL Item
Infiltrating lobular carcinoma (36)
CL Item
Tubular adenocarcinoma (9)
CL Item
Unknown (U)
CL Item
Other, Specify (OT)
Histology at initial diagnosis, other
Item
Other histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3172269 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Histological Grade at Initial Diagnosis
integer
C0677930 (UMLS CUI [1,1])
C0919553 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0919553 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
CL Item
Grade cannot be assessed (0)
CL Item
Well differentiated (1)
CL Item
Moderately differentiated (2)
CL Item
Poorly differentiated (3)
CL Item
Undifferentiated (4)
Date of last progression
Item
Date of last progression
partialDate
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Date of Staging at Screening
Item
Date of Staging at Screening
partialDate
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
CL Item
0 (0)
CL Item
I (1)
CL Item
Ia (1A)
CL Item
1b (1B)
CL Item
1c (1C)
CL Item
II (2)
CL Item
IIa (2A)
CL Item
IIb (2B)
CL Item
IIc (2C)
CL Item
III (3)
CL Item
IIIa (3A)
CL Item
IIIb (3B)
CL Item
IIIc (3C)
CL Item
IV (4)
CL Item
IVa (4A)
CL Item
IVb (4B)
CL Item
IVc (4C)
Item
Extent of Disease at Screening
text
C0220908 (UMLS CUI [1,1])
C0449279 (UMLS CUI [1,2])
C0449279 (UMLS CUI [1,2])
CL Item
Limited (1)
CL Item
Extensive (2)
CL Item
Local Unresectable (3)
CL Item
Metastatic (4)
CL Item
Unknown (U)
Item
Primary tumor In Situ
text
C0677930 (UMLS CUI [1,1])
C0007099 (UMLS CUI [1,2])
C0007099 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Date of ErbB2 Biopsy
Item
Date of ErbB2 Biopsy
partialDate
C0005558 (UMLS CUI [1,1])
C1512413 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1512413 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Disease Setting for the Biopsy
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
CL Item
Initial Diagnosis (1)
CL Item
At Recurrence/Relapse (2)
Item
ErbB2 (Her2/neu) Status ImmunoHisto-Chemistry (IHC)
text
C1512413 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,2])
CL Item
0 (0)
CL Item
1+ (1)
CL Item
2+ (2)
CL Item
3+ (3)
CL Item
Unknown (U)
Item
Fluorescence in Situ Hybridization (FISH)
text
C0162789 (UMLS CUI [1])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Borderline (3)
CL Item
Unknwon (U)
Item
Chromogenic in Situ Hybridization (CISH)
text
C1516514 (UMLS CUI [1])
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Borderline (3)
CL Item
Unknown (U)
Item Group
Disease characteristics
C0599878 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
C0205394 (UMLS CUI-2)
C0006826 (UMLS CUI-3)
Item
Primary tumor at initial diagnosis
text
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
CL Item
Anus (1)
CL Item
BIle Duct (3)
CL Item
Bladder (2)
CL Item
Bone (4)
CL Item
Brain (5)
CL Item
Cervix (7)
CL Item
CNS (8)
CL Item
Colon/Rectum (9)
CL Item
Endometrium/Uterus (10)
CL Item
Eosophagus/Oesophagus (11)
CL Item
Fallopian Tube (42)
CL Item
Gall Bladder (12)
CL Item
Gastric (35)
CL Item
Gastric Cardia (45)
CL Item
Gastroesophageal Junction (46)
CL Item
Head and Neck (13)
CL Item
Kaposi's Sarcoma (15)
CL Item
Kidney (16)
CL Item
Liver (17)
CL Item
Melanoma (19)
CL Item
Mesothelioma (20)
CL Item
Mouth (21)
CL Item
Neuroblastoma (26)
CL Item
Neuroendocrine (47)
CL Item
Non-Small Cell Lung (25)
CL Item
Ovary (27)
CL Item
Pancreas (28)
CL Item
Primary Peritoneal (43)
CL Item
Prostate (29)
CL Item
Renal Cell (44)
CL Item
Retinoblastoma (30)
CL Item
Salivary Glands (31)
CL Item
Small Cell Lung (33)
CL Item
Small Intestine (32)
CL Item
Soft Tissue Sarcoma (34)
CL Item
Testicle (36)
CL Item
Thyroid (37)
CL Item
Vagina (38)
CL Item
Vulva (39)
CL Item
Wilm's Tumour (40)
CL Item
Unknown (U)
CL Item
Other, Specify (OT)
Primary tumor type at initial diagnosis, other
Item
Other Primary tumor at initial diagnosis
text
C0677930 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Date of initial diagnosis
Item
Date of initial diagnosis
partialDate
C2316983 (UMLS CUI [1,1])
C0205265 (UMLS CUI [1,2])
C0205265 (UMLS CUI [1,2])
Item
TNM Staging at initial diagnosis, primary tumor
text
C4071762 (UMLS CUI [1,1])
C0475455 (UMLS CUI [1,2])
C0475455 (UMLS CUI [1,2])
Code List
TNM Staging at initial diagnosis, primary tumor
CL Item
T0 (T0)
CL Item
T1 (T1)
CL Item
T1A (T1a)
CL Item
T1B (T1b)
CL Item
T1C (T1c)
CL Item
T2 (T2)
CL Item
T2A (T2a)
CL Item
T2B (T2b)
CL Item
T2C (T2c)
CL Item
T3 (T3)
CL Item
T3A (T3a)
CL Item
T3B (T3b)
CL Item
T3C (T3c)
CL Item
T4 (T4)
CL Item
TIS (TIS)
CL Item
TX (TX)
Item
TNM Stage at initial diagnosis, regional lymph nodes
text
C4071762 (UMLS CUI [1,1])
C0456532 (UMLS CUI [1,2])
C0456532 (UMLS CUI [1,2])
Code List
TNM Stage at initial diagnosis, regional lymph nodes
CL Item
NOI+ (N0i+)
CL Item
N1 (N1)
CL Item
N1MI (N1mi)
CL Item
N2 (N2)
CL Item
N2A (N2A)
CL Item
N2B (N2B)
CL Item
N2C (N2C)
CL Item
N3 (N3)
CL Item
NX (NX)
CL Item
N0 (N0)
Item
TNM Stage at initial diagnosis, distant metastasis
text
C4071762 (UMLS CUI [1,1])
C0456533 (UMLS CUI [1,2])
C0456533 (UMLS CUI [1,2])
Code List
TNM Stage at initial diagnosis, distant metastasis
CL Item
M0 (M0)
CL Item
M1 (M1)
CL Item
MX (MX)
Item
Histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C3172269 (UMLS CUI [1,2])
CL Item
Infiltrating ductal NOS (12)
CL Item
Infiltrating lobular carcinoma (36)
CL Item
Unknown (U)
CL Item
Other, Specify (OT)
CL Item
Acral lentiginous melanoma (21)
CL Item
Adenocarcinoma (1)
CL Item
Adenosquamous carcinoma (41)
CL Item
Anaplastic astrocytoma (42)
CL Item
Anaplastic oligodendroglioma (43)
CL Item
Atypical ductal hyperplasia (ADH) (32)
CL Item
Balloon cell melanoma (25)
CL Item
Blue nevus, malignant (26)
CL Item
Bronchioalveolar (6)
CL Item
Carcinoid tumor (51)
CL Item
Carcinosarcoma (55)
CL Item
Clear cell (13)
CL Item
Desmoplastic melanoma (22)
CL Item
Ductal carcinoma in situ (DCIS) (34)
CL Item
Epithelial cell (29)
CL Item
Epithelioid cell melanoma (23)
CL Item
Glioblastoma multiforme (45)
CL Item
Gliosarcoma (46)
CL Item
Hepatocellular Carcinoma (47)
CL Item
High Grade Transitional Cell (53)
CL Item
Infiltrating carcinoma (35)
CL Item
Inflammatory breast carcinoma (37)
CL Item
Insitu breast carcinoma (40)
CL Item
Invasive breast carcinoma (39)
CL Item
Large cell carcinoma (28)
CL Item
Lentigo maligna melanoma (20)
CL Item
Lobular carcinoma in situ (LCIS) (33)
CL Item
Lobular invasive (8)
CL Item
Low Grade Transitional Cell (52)
CL Item
Malignant endometrioid tumours (4)
CL Item
Malignant melanoma in giant pigmented nevus (27)
CL Item
Malignant melanoma NOS (17)
CL Item
Malignant mucinous tumours (3)
CL Item
Malignant serous tumours (2)
CL Item
Medullary (10)
CL Item
Melanoma in situ (16)
CL Item
Metaplastic breast carcinoma (38)
CL Item
Mixed anaplastic oligoastrocytoma (44)
CL Item
Mixed epithelial cell (14)
CL Item
Mucinous adenocarcinoma (50)
CL Item
Nodular melanoma (19)
CL Item
Papillary adenocarcinoma (11)
CL Item
Papillary Serous (54)
CL Item
Poorly differentiated adenocarcinoma (48)
CL Item
Predominantly clear cell (31)
CL Item
Sarcoma (30)
CL Item
Signet-ring cell carcinoma (49)
CL Item
Spindle cell melanoma (24)
CL Item
Squamous cell carcinoma (7)
CL Item
Superficial spreading melanoma (18)
CL Item
Undifferentiated adenocarcinoma (15)
CL Item
Undifferentiated carcinoma (5)
Histology at initial diagnosis, other
Item
Other histology at initial diagnosis
text
C0019638 (UMLS CUI [1,1])
C3172269 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C3172269 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Histological Grade at Initial Diagnosis
integer
C0919553 (UMLS CUI [1,1])
C4071762 (UMLS CUI [1,2])
C4071762 (UMLS CUI [1,2])
CL Item
Grade cannot be assessed (0)
CL Item
Well differentiated (1)
CL Item
Moderately differentiated (2)
CL Item
Poorly differentiated (3)
CL Item
Undifferentiated (4)
Date of last progression
Item
Date of last progression
partialDate
C0242656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
Date of Staging at Screening
Item
Date of Staging at Screening
partialDate
C0011008 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
C0027646 (UMLS CUI [1,2])
C1710477 (UMLS CUI [1,3])
CL Item
0 (0)
CL Item
I (1)
CL Item
Ia (1A)
CL Item
1b (1B)
CL Item
1c (1C)
CL Item
II (2)
CL Item
IIa (2A)
CL Item
IIb (2B)
CL Item
IIc (2C)
CL Item
III (3)
CL Item
IIIa (3A)
CL Item
IIIb (3B)
CL Item
IIIc (3C)
CL Item
IV (4)
CL Item
IVa (4A)
CL Item
IVb (4B)
CL Item
IVc (4C)
Item
Extent of Disease at Screening
text
C0220908 (UMLS CUI [1,1])
C0449279 (UMLS CUI [1,2])
C0449279 (UMLS CUI [1,2])
CL Item
Limited (1)
CL Item
Extensive (2)
CL Item
Local Unresectable (3)
CL Item
Metastatic (4)
CL Item
Unknown (U)
Item
Primary tumor In Situ
text
C0677930 (UMLS CUI [1,1])
C0007099 (UMLS CUI [1,2])
C0007099 (UMLS CUI [1,2])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Unknown (U)
Item Group
Metastatic disease characteristics
C0599878 (UMLS CUI-1)
C0027627 (UMLS CUI-2)
C0027627 (UMLS CUI-2)
Item
Metastatic Disease at Screening
text
C0027627 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,2])
CL Item
Yes, Complete Date Metastatic Disease was First Diagnosed (Y)
CL Item
No (N)
initial Neoplasm Metastatis, Date
Item
Metastatic Disease at Screening, Date
partialDate
C0027627 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0449976 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0449976 (UMLS CUI [1,3])
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Assessed (NA)
Other to specify
Item
Other to specify
text
C0205394 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])