ID

42525

Description

Re-differentiation of Radioiodine-Refractory BRAF V600E-mutant Papillary Thyroid Carcinoma With GSK2118436; ODM derived from: https://clinicaltrials.gov/show/NCT01534897

Link

https://clinicaltrials.gov/show/NCT01534897

Keywords

Versions (1)
  1. 8/18/21 8/18/21 -
Copyright Holder

Massachusetts General Hospital GlaxoSmithKline

Uploaded on

August 18, 2021

DOI

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License

Creative Commons BY-NC 4.0
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Eligibility Papillary Thyroid Carcinoma NCT01534897

English

Eligibility Papillary Thyroid Carcinoma NCT01534897

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed papillary thyroid carcinoma, including its variants, such as tall cell ptc or poorly differentiated thyroid carcinoma, that is metastatic or unresectable and harbors a braf v600e mutation
Description

Histologically confirmed papillary thyroid carcinoma, including its variants

Data type

boolean

Alias
UMLS CUI [1,1]
C0238463
UMLS CUI [1,2]
C0332257
UMLS CUI [1,3]
C0205419
evaluable disease, as defined by at least one lesion that can be accurately measured in at least one dimension on ct scan or ultrasound, if present in the neck
Description

Evaluable disease | Measurable disease by CT or ultrasound (neck localization)

Data type

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0040405
UMLS CUI [3,1]
C1513041
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0041618
UMLS CUI [3,4]
C0027530
UMLS CUI [3,5]
C0475264
radioiodine-refractory disease
Description

Radioiodine refractory disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0303029
UMLS CUI [1,2]
C0205269
life expectancy > 6 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
able to swallow and retain oral medication
Description

Able to swallow and retain oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C0175795
UMLS CUI [1,2]
C2712086
UMLS CUI [2,1]
C0175795
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0085732
normal organ and marrow function
Description

Normal organ function | Normal bone marrow function

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205307
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [2,3]
C0205307
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breastfeeding
Description

Pregnancy | Breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous treatment with a specific braf or mek inhibitor
Description

Prior therapy with a specific BRAF or MEK inhibitor

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C3838813
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1513344
receiving any other study agents
Description

Other therapy with experimental drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0418967
UMLS CUI [1,2]
C0304229
known brain metastases
Description

Brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
history of allergic reactions attributed to compounds of similar chemical or biologic composition to gsk2118436, bovine tsh, mannitol or iodine
Description

Hypersensitivity to compounds of similar chemical or biologic composition to gsk2118436, bovine tsh, mannitol or iodine

Data type

boolean

Alias
UMLS CUI [1,1]
C2826139
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C2348205
UMLS CUI [1,4]
C0020517
UMLS CUI [2,1]
C0040160
UMLS CUI [2,2]
C3667982
UMLS CUI [2,3]
C1706082
UMLS CUI [2,4]
C2348205
UMLS CUI [2,5]
C0020517
UMLS CUI [3,1]
C0024730
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C2348205
UMLS CUI [3,4]
C0020517
UMLS CUI [4,1]
C0021968
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C2348205
UMLS CUI [4,4]
C0020517
active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs
Description

Active gastrointestinal disease | Condition interfering with the absorption of drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C2707252
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013227
UMLS CUI [2,5]
C2826293
history of known glucose-6-phosphate dehyrogenase (g6pd) deficiency
Description

Glucose-6-phosphate dehyrogenase deficiency

Data type

boolean

Alias
UMLS CUI [1,1]
C2939465
UMLS CUI [1,2]
C0262926
corrected qt interval >/= 480 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; class ii, iii, or iv heart failure, abnormal cardiac valve morphology; or history of known cardiac arrhythmias
Description

Corrected qt interval | History of acute coronary syndromes | Coronary angioplasty recent | Coronary stenting recent | Heart failure, NYHA classification | Abnormal cardiac valve morphology | History of known cardiac arrhythmias

Data type

boolean

Alias
UMLS CUI [1]
C0855331
UMLS CUI [2,1]
C0948089
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0190211
UMLS CUI [3,2]
C0332185
UMLS CUI [4,1]
C0948884
UMLS CUI [4,2]
C0332185
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0018826
UMLS CUI [6,2]
C0332437
UMLS CUI [6,3]
C0205161
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C0262926
taking herbal remedies
Description

Herbal remedies

Data type

boolean

Alias
UMLS CUI [1]
C2240391
subjects with significant symptoms from their thyroid cancer, or have a large burden of rapidly progressive iodine-refractory ptc who are in need of other systemic therapy, as judged by their treating physician
Description

Significant symptoms of thyroid cancer | Rapidly progressive iodine-refractory ptc in need of other systemic therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0238463
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C2826293
UMLS CUI [2,1]
C0238463
UMLS CUI [2,2]
C1838681
UMLS CUI [2,3]
C0303029
UMLS CUI [2,4]
C0205269
UMLS CUI [2,5]
C0920425
UMLS CUI [2,6]
C0205373
UMLS CUI [2,7]
C0027552
uncontrolled current illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements
Description

Uncontrolled comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
history of a different malignancy unless disease-free for at least 5 years and deemed to be at low risk for recurrence
Description

History of a different malignancy unless disease-free for at least 5 years and deemed to be at low risk for recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [2,5]
C0034897
UMLS CUI [2,6]
C3538919
hiv-positive on combination antiretroviral therapy
Description

HIV seropositivity on combination antiretroviral therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C1963724
UMLS CUI [1,3]
C0205195
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Similar models

Eligibility Papillary Thyroid Carcinoma NCT01534897

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Histologically confirmed papillary thyroid carcinoma, including its variants
Item
histologically confirmed papillary thyroid carcinoma, including its variants, such as tall cell ptc or poorly differentiated thyroid carcinoma, that is metastatic or unresectable and harbors a braf v600e mutation
boolean
C0238463 (UMLS CUI [1,1])
C0332257 (UMLS CUI [1,2])
C0205419 (UMLS CUI [1,3])
Evaluable disease | Measurable disease by CT or ultrasound (neck localization)
Item
evaluable disease, as defined by at least one lesion that can be accurately measured in at least one dimension on ct scan or ultrasound, if present in the neck
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
C1513041 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0041618 (UMLS CUI [3,3])
C0027530 (UMLS CUI [3,4])
C0475264 (UMLS CUI [3,5])
Radioiodine refractory disease
Item
radioiodine-refractory disease
boolean
C0303029 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
Life expectancy
Item
life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Able to swallow and retain oral medication
Item
able to swallow and retain oral medication
boolean
C0175795 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0175795 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Normal organ function | Normal bone marrow function
Item
normal organ and marrow function
boolean
C0678852 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breastfeeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior therapy with a specific BRAF or MEK inhibitor
Item
previous treatment with a specific braf or mek inhibitor
boolean
C1514463 (UMLS CUI [1,1])
C3838813 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C1513344 (UMLS CUI [2,2])
Other therapy with experimental drug
Item
receiving any other study agents
boolean
C0418967 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Brain metastases
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
Hypersensitivity to compounds of similar chemical or biologic composition to gsk2118436, bovine tsh, mannitol or iodine
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to gsk2118436, bovine tsh, mannitol or iodine
boolean
C2826139 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C2348205 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,4])
C0040160 (UMLS CUI [2,1])
C3667982 (UMLS CUI [2,2])
C1706082 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C0020517 (UMLS CUI [2,5])
C0024730 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C0020517 (UMLS CUI [3,4])
C0021968 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C0020517 (UMLS CUI [4,4])
Active gastrointestinal disease | Condition interfering with the absorption of drugs
Item
active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs
boolean
C0017178 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013227 (UMLS CUI [2,4])
C2826293 (UMLS CUI [2,5])
Glucose-6-phosphate dehyrogenase deficiency
Item
history of known glucose-6-phosphate dehyrogenase (g6pd) deficiency
boolean
C2939465 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
Corrected qt interval | History of acute coronary syndromes | Coronary angioplasty recent | Coronary stenting recent | Heart failure, NYHA classification | Abnormal cardiac valve morphology | History of known cardiac arrhythmias
Item
corrected qt interval >/= 480 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; class ii, iii, or iv heart failure, abnormal cardiac valve morphology; or history of known cardiac arrhythmias
boolean
C0855331 (UMLS CUI [1])
C0948089 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0190211 (UMLS CUI [3,1])
C0332185 (UMLS CUI [3,2])
C0948884 (UMLS CUI [4,1])
C0332185 (UMLS CUI [4,2])
C0018801 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0018826 (UMLS CUI [6,1])
C0332437 (UMLS CUI [6,2])
C0205161 (UMLS CUI [6,3])
C0003811 (UMLS CUI [7,1])
C0262926 (UMLS CUI [7,2])
Herbal remedies
Item
taking herbal remedies
boolean
C2240391 (UMLS CUI [1])
Significant symptoms of thyroid cancer | Rapidly progressive iodine-refractory ptc in need of other systemic therapy
Item
subjects with significant symptoms from their thyroid cancer, or have a large burden of rapidly progressive iodine-refractory ptc who are in need of other systemic therapy, as judged by their treating physician
boolean
C0238463 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0238463 (UMLS CUI [2,1])
C1838681 (UMLS CUI [2,2])
C0303029 (UMLS CUI [2,3])
C0205269 (UMLS CUI [2,4])
C0920425 (UMLS CUI [2,5])
C0205373 (UMLS CUI [2,6])
C0027552 (UMLS CUI [2,7])
Uncontrolled comorbidity
Item
uncontrolled current illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
History of a different malignancy unless disease-free for at least 5 years and deemed to be at low risk for recurrence
Item
history of a different malignancy unless disease-free for at least 5 years and deemed to be at low risk for recurrence
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C0034897 (UMLS CUI [2,5])
C3538919 (UMLS CUI [2,6])
HIV seropositivity on combination antiretroviral therapy
Item
hiv-positive on combination antiretroviral therapy
boolean
C0019699 (UMLS CUI [1,1])
C1963724 (UMLS CUI [1,2])
C0205195 (UMLS CUI [1,3])
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