ID

30254

Beschreibung

https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Link

https://clinicaltrials.gov/ct2/show/NCT00486954

Stichworte

Versionen (1)
  1. 25.05.18 25.05.18 - Halim Ugurlu
Rechteinhaber

GlaxoSmithKline (GSK)

Hochgeladen am

25. Mai 2018

DOI

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Lizenz

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Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer

Englisch

Screening-1 (date of visit, identification, eligibility, demography, age)

1 Formulare  
Inform Screening
Beschreibung

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject Initials [hidden]
Beschreibung

Subject Initials

Datentyp

text

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Inform Enrollment
Beschreibung

Inform Enrollment

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C1516879
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschreibung

Date of visit

Alias
UMLS CUI-1
C1320303
Date of visit
Beschreibung

Date of visit

Datentyp

text

Alias
UMLS CUI [1]
C1320303
Subject Identification
Beschreibung

Subject Identification

Alias
UMLS CUI-1
C2348585
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Inclusion criteria
Beschreibung

Inclusion criteria

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
Signed informed consent
Beschreibung

Signed informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0742766
Male or female; ≥ 20 years (at the time of giving consent)
Beschreibung

Male or female; ≥ 20 years (at the time of giving consent)

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status
Beschreibung

Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0699791
UMLS CUI [1,2]
C1515560
UMLS CUI [1,3]
C0332291
Prior regimen for gastric carcinoma and developed disease progression or recurrence
Beschreibung

Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0699791
UMLS CUI [1,3]
C0242656
UMLS CUI [2]
C0034897
Left ventricular ejection fraction (LVEF)
Beschreibung

Left ventricular ejection fraction (LVEF) within institutional range of normal as measured by echocardiogram (ECHO). Multigated acquisition (MUGA) scans will be accepted in cases where an echocardiogram cannot be performed or is inconclusive (LVEF of ≥50% required if normal range of LVEF is not provided by institution)

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
ECOG Performance Status of 0 to 1
Beschreibung

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Able to swallow and retain oral medication
Beschreibung

Able to swallow and retain oral medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [1,3]
C0333118
UMLS CUI [1,4]
C0085732
Willing to practice acceptable methods of birth control during the study
Beschreibung

Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1879533
Washout period from the prior last therapy
Beschreibung

Washout period from the prior last therapy as follows; Chemotherapy (except for agents below) 4 weeks (I.V) Chemotherapy (except for agents below) 2 weeks (P.O) Trastuzumab, Bevacizumab 4 weeks Mitomycin-C, nitrosourea 6 weeks Radiotherapy, Immunotherapy, Biologic therapy and Surgery (except for minor surgical procedure) 2 weeks

Datentyp

boolean

Alias
UMLS CUI [1]
C1710661
Willing to complete all screening assessments as outlined in the protocol
Beschreibung

Willing to complete all screening assessments as outlined in the protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C0525058
Adequate organ function
Beschreibung

Adequate organ function as defined in Table 2 Baseline Laboratory Values

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205411
UMLS CUI [1,2]
C0678852
Able to be hospitalized for PK analysis during cycle 1
Beschreibung

Able to be hospitalized for PK analysis during cycle 1

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0201734
Life expectancy of at least 12 weeks from the first dose of study treatment)
Beschreibung

Life expectancy of at least 12 weeks from the first dose of study treatment)

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Pregnant or lactating female at anytime during the study
Beschreibung

Pregnant or lactating female at anytime during the study

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
Planned concurrent anti-cancer therapy
Beschreibung

Planned concurrent anti-cancer therapy (chemotherapy, radiotherapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205420
serious toxicity from prior cancer treatment
Beschreibung

Unresolved or unstable, serious toxicity from prior cancer treatment (any toxicities greater than grade 2)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0920425
Peripheral neuropathy of Grade 2 or greater
Beschreibung

Peripheral neuropathy of Grade 2 or greater

Datentyp

boolean

Alias
UMLS CUI [1]
C0031117
Malabsorption syndrome
Beschreibung

Malabsorption syndrome, disease significantly affecting gastrointestinal function. Subjects with ulcerative colitis and Crohn's disease are also excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0024523
History of other malignancy
Beschreibung

History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
Concurrent disease or condition
Beschreibung

Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject's safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
Life threatening infection
Beschreibung

Life threatening infection

Datentyp

boolean

Alias
UMLS CUI [1]
C1859430
Dementia, altered mental status, or any psychiatric condition
Beschreibung

Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0278061
Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
Beschreibung

Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0002965
UMLS CUI [1,3]
C0003811
UMLS CUI [1,4]
C0018802
Known history or clinical evidence of central nervous system (CNS) metastasis
Beschreibung

Known history or clinical evidence of central nervous system (CNS) metastasis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332120
Concurrent treatment with prohibited medications
Beschreibung

Concurrent treatment with prohibited medications, including herbal remedies and Chinese traditional medicines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C3242263
Concurrent treatment with an investigational agent
Beschreibung

Concurrent treatment with an investigational agent within 28 days prior to the administration of paclitaxel and/or lapatinib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1875319
UMLS CUI [1,2]
C1875319
UMLS CUI [1,3]
C0009429
hypersensitivity reaction
Beschreibung

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to paclitaxel, including polyethoxylated castor oil, alcohol, or lapatinib or their excipients

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
pulmonary disorder
Beschreibung

Anamnesis or diagnosis of pulmonary disorder, such as interstitial pneumonia, pulmonary fibrosis or serious hypoxia

Datentyp

boolean

Alias
UMLS CUI [1]
C1096000
Gastrectomy surgery
Beschreibung

Gastrectomy surgery if Pilot Part of the study determines that partial gastrectomy (pylorus spared) or total/partial gastrectomy (pylorus removed) has a significant negative impact upon lapatinib PK and safety profile

Datentyp

boolean

Alias
UMLS CUI [1]
C0017118
UMLS CUI [2]
C0030600
EGFR agent (except Trastuzumab)
Beschreibung

Known history of use of any EGFR agent (except Trastuzumab)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1443775
UMLS CUI [1,2]
C0262926
Prior gastric cancer treatment which included a taxane.
Beschreibung

Prior gastric cancer treatment which included a taxane.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0699791
UMLS CUI [1,3]
C0796419
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Beschreibung

Eligibility Question

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Demography
Beschreibung

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Gender

Datentyp

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Beschreibung

Geographic Ancestry

Datentyp

integer

Alias
UMLS CUI [1]
C3841890
Age
Beschreibung

Age

Alias
UMLS CUI-1
C0001779
Age in years
Beschreibung

Age in years

Datentyp

text

Alias
UMLS CUI [1]
C0001779
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Ähnliche Modelle

Screening-1 (date of visit, identification, eligibility, demography, age)

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Subject Initials
Item
Subject Initials [hidden]
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item Group
Inform Enrollment
C0021430 (UMLS CUI-1)
C1516879 (UMLS CUI-2)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit
Item
Date of visit
text
C1320303 (UMLS CUI [1])
Item Group
Subject Identification
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Signed informed consent
Item
Signed informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0742766 (UMLS CUI [1,2])
Male or female; ≥ 20 years (at the time of giving consent)
Item
Male or female; ≥ 20 years (at the time of giving consent)
boolean
C0001779 (UMLS CUI [1])
Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status
Item
Any histologically or cytologically confirmed gastric carcinoma independent of tumor ErbB2 status
boolean
C0699791 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
C0332291 (UMLS CUI [1,3])
Subjects who have received one prior regimen for gastric carcinoma and developed disease progression or recurrence. The regimen must have contained 5-fluoropyrimidine and/or cisplatin
Item
Prior regimen for gastric carcinoma and developed disease progression or recurrence
boolean
C0392920 (UMLS CUI [1,1])
C0699791 (UMLS CUI [1,2])
C0242656 (UMLS CUI [1,3])
C0034897 (UMLS CUI [2])
Left ventricular ejection fraction (LVEF)
Item
Left ventricular ejection fraction (LVEF)
boolean
C0428772 (UMLS CUI [1])
ECOG Performance Status of 0 to 1
Item
ECOG Performance Status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Able to swallow and retain oral medication
Item
Able to swallow and retain oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0333118 (UMLS CUI [1,3])
C0085732 (UMLS CUI [1,4])
acceptable methods of birth control
Item
Willing to practice acceptable methods of birth control during the study
boolean
C0700589 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Washout period
Item
Washout period from the prior last therapy
boolean
C1710661 (UMLS CUI [1])
Willing to complete all screening assessments as outlined in the protocol
Item
Willing to complete all screening assessments as outlined in the protocol
boolean
C0525058 (UMLS CUI [1])
Adequate organ function
Item
Adequate organ function
boolean
C0205411 (UMLS CUI [1,1])
C0678852 (UMLS CUI [1,2])
hospitalized for PK analysis during cycle 1
Item
Able to be hospitalized for PK analysis during cycle 1
boolean
C0019993 (UMLS CUI [1,1])
C0201734 (UMLS CUI [1,2])
Life expectancy
Item
Life expectancy of at least 12 weeks from the first dose of study treatment)
boolean
C0023671 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Pregnant or lactating female at anytime during the study
Item
Pregnant or lactating female at anytime during the study
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
Planned concurrent anti-cancer therapy
Item
Planned concurrent anti-cancer therapy
boolean
C0920425 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
serious toxicity from prior cancer treatment
Item
serious toxicity from prior cancer treatment
boolean
C0600688 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Peripheral neuropathy of Grade 2 or greater
Item
Peripheral neuropathy of Grade 2 or greater
boolean
C0031117 (UMLS CUI [1])
Malabsorption syndrome
Item
Malabsorption syndrome
boolean
C0024523 (UMLS CUI [1])
History of other malignancy
Item
History of other malignancy
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Concurrent disease or condition
Item
Concurrent disease or condition
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Life threatening infection
Item
Life threatening infection
boolean
C1859430 (UMLS CUI [1])
Dementia, altered mental status, or any psychiatric condition
Item
Dementia, altered mental status, or any psychiatric condition
boolean
C0497327 (UMLS CUI [1,1])
C0278061 (UMLS CUI [1,2])
Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
Item
Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
boolean
C0262926 (UMLS CUI [1,1])
C0002965 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,3])
C0018802 (UMLS CUI [1,4])
Known history or clinical evidence of central nervous system (CNS) metastasis
Item
Known history or clinical evidence of central nervous system (CNS) metastasis
boolean
C0686377 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
Concurrent treatment with prohibited medications
Item
Concurrent treatment with prohibited medications
boolean
C0013227 (UMLS CUI [1,1])
C3242263 (UMLS CUI [1,2])
Concurrent treatment with an investigational agent
Item
Concurrent treatment with an investigational agent
boolean
C1875319 (UMLS CUI [1,1])
C1875319 (UMLS CUI [1,2])
C0009429 (UMLS CUI [1,3])
hypersensitivity reaction
Item
hypersensitivity reaction
boolean
C0020517 (UMLS CUI [1])
pulmonary disorder
Item
pulmonary disorder
boolean
C1096000 (UMLS CUI [1])
Gastrectomy surgery
Item
Gastrectomy surgery
boolean
C0017118 (UMLS CUI [1])
C0030600 (UMLS CUI [2])
EGFR agent
Item
EGFR agent (except Trastuzumab)
boolean
C1443775 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Prior gastric cancer treatment which included a taxane.
Item
Prior gastric cancer treatment which included a taxane.
boolean
C0920425 (UMLS CUI [1,1])
C0699791 (UMLS CUI [1,2])
C0796419 (UMLS CUI [1,3])
Item Group
Eligibility Question
C0013893 (UMLS CUI-1)
Eligibility Question
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
CL Item
Female, post menopausal (3)
CL Item
Female, sterile (of child-bearing age) (4)
CL Item
Female, potentially able to bear children (5)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or latino (1)
CL Item
Not hispanic or latino (2)
Item
Geographic Ancestry
integer
C3841890 (UMLS CUI [1])
Geographic Ancestry
Code List
Geographic Ancestry
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaaian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Age
C0001779 (UMLS CUI-1)
Age in years
Item
Age in years
text
C0001779 (UMLS CUI [1])
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