ID

20826

Description

A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT00358930

Link

https://clinicaltrials.gov/show/NCT00358930

Keywords

Versions (1)
  1. 3/20/17 3/20/17 -
Uploaded on

March 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Head and Neck Neoplasms NCT00358930

English

Eligibility Head and Neck Neoplasms NCT00358930

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. able to provide signed and dated informed consent document prior to study-specific screening procedures.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. histologically or cytologically confirmed locally advanced, recurrent or metastatic scchn.
Description

Squamous cell carcinoma of the head and neck Advanced Local | Squamous cell carcinoma of the head and neck Recurrent | Squamous cell carcinoma of the head and neck metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C1168401
UMLS CUI [2,2]
C2945760
UMLS CUI [3,1]
C1168401
UMLS CUI [3,2]
C1522484
3. measurable disease per recist.
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
4. ≥ 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. karnofsky performance status (kps) ≥ 70%.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
6. male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of arq 501.
Description

Fertility Contraceptive methods | Fertility Avoidance of pregnancy

Data type

boolean

Alias
UMLS CUI [1,1]
C0015895
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0015895
UMLS CUI [2,2]
C1821946
7. hemoglobin (hgb) ≥ 10 g/dl.
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
8. absolute neutrophil count (anc) ≥ 1.5 x 10^9/l (≥ 1,500/mm³).
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
9. platelet count ≥ 100 x 10^9/l ( ≥ 100,000/mm³).
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
10. total bilirubin less than or equal to 1.5 x upper limit of normal (uln) or less than or equal to 3.0 x uln with metastatic liver disease.
Description

Serum total bilirubin measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0494165
11. aspartate aminotransferase (ast) and alanine aminotransferase (alt) less than or equal to 2.5 x uln or less than or equal to 5.0 x uln with metastatic liver disease.
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0494165
12. creatinine less than or equal to 1.5 x uln.
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. primary tumor of nasopharyngeal origin.
Description

Nasopharyngeal Neoplasm Primary

Data type

boolean

Alias
UMLS CUI [1,1]
C0027439
UMLS CUI [1,2]
C0205225
2. eligible for curative surgery or radiotherapy.
Description

Curative Surgery Patient Appropriate | Therapeutic radiology procedure Patient Appropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C1511562
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C1548787
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0030705
UMLS CUI [2,3]
C1548787
3. received three or more systemic anticancer regimens.
Description

Cancer treatment Systemic Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C1265611
4. have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
Description

Sepsis Uncontrolled Opportunistic | Sepsis Uncontrolled Life Threatening | Sepsis Uncontrolled Clinical Significance

Data type

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0029118
UMLS CUI [2,1]
C0243026
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2826244
UMLS CUI [3,1]
C0243026
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C2826293
5. have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion.
Description

Chemotherapy Malignant Neoplasm | Immunotherapy Malignant Neoplasm | Therapeutic radiology procedure Malignant Neoplasm | Investigational New Drugs Malignant Neoplasm

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C0006826
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0006826
UMLS CUI [4,1]
C0013230
UMLS CUI [4,2]
C0006826
6. surgery within two weeks of first infusion.
Description

Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0543467
7. have symptomatic or untreated central nervous system (cns) involvement.
Description

Central Nervous System Involvement Symptomatic | Central Nervous System Involvement untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C4050309
UMLS CUI [2,2]
C0332155
8. are pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
9. previous exposure to arq 501.
Description

ARQ 501 Exposure to

Data type

boolean

Alias
UMLS CUI [1,1]
C1328233
UMLS CUI [1,2]
C0332157
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Similar models

Eligibility Head and Neck Neoplasms NCT00358930

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. able to provide signed and dated informed consent document prior to study-specific screening procedures.
boolean
C0021430 (UMLS CUI [1])
Squamous cell carcinoma of the head and neck Advanced Local | Squamous cell carcinoma of the head and neck Recurrent | Squamous cell carcinoma of the head and neck metastatic
Item
2. histologically or cytologically confirmed locally advanced, recurrent or metastatic scchn.
boolean
C1168401 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C1168401 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
C1168401 (UMLS CUI [3,1])
C1522484 (UMLS CUI [3,2])
Measurable Disease
Item
3. measurable disease per recist.
boolean
C1513041 (UMLS CUI [1])
Age
Item
4. ≥ 18 years old.
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
5. karnofsky performance status (kps) ≥ 70%.
boolean
C0206065 (UMLS CUI [1])
Fertility Contraceptive methods | Fertility Avoidance of pregnancy
Item
6. male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of arq 501.
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015895 (UMLS CUI [2,1])
C1821946 (UMLS CUI [2,2])
Hemoglobin measurement
Item
7. hemoglobin (hgb) ≥ 10 g/dl.
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
8. absolute neutrophil count (anc) ≥ 1.5 x 10^9/l (≥ 1,500/mm³).
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
9. platelet count ≥ 100 x 10^9/l ( ≥ 100,000/mm³).
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement | Secondary malignant neoplasm of liver
Item
10. total bilirubin less than or equal to 1.5 x upper limit of normal (uln) or less than or equal to 3.0 x uln with metastatic liver disease.
boolean
C1278039 (UMLS CUI [1])
C0494165 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Secondary malignant neoplasm of liver
Item
11. aspartate aminotransferase (ast) and alanine aminotransferase (alt) less than or equal to 2.5 x uln or less than or equal to 5.0 x uln with metastatic liver disease.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
Creatinine measurement, serum
Item
12. creatinine less than or equal to 1.5 x uln.
boolean
C0201976 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Nasopharyngeal Neoplasm Primary
Item
1. primary tumor of nasopharyngeal origin.
boolean
C0027439 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
Curative Surgery Patient Appropriate | Therapeutic radiology procedure Patient Appropriate
Item
2. eligible for curative surgery or radiotherapy.
boolean
C1511562 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C1548787 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0030705 (UMLS CUI [2,2])
C1548787 (UMLS CUI [2,3])
Cancer treatment Systemic Quantity
Item
3. received three or more systemic anticancer regimens.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Sepsis Uncontrolled Opportunistic | Sepsis Uncontrolled Life Threatening | Sepsis Uncontrolled Clinical Significance
Item
4. have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0029118 (UMLS CUI [1,3])
C0243026 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2826244 (UMLS CUI [2,3])
C0243026 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C2826293 (UMLS CUI [3,3])
Chemotherapy Malignant Neoplasm | Immunotherapy Malignant Neoplasm | Therapeutic radiology procedure Malignant Neoplasm | Investigational New Drugs Malignant Neoplasm
Item
5. have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion.
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0006826 (UMLS CUI [3,2])
C0013230 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
Operative Surgical Procedures
Item
6. surgery within two weeks of first infusion.
boolean
C0543467 (UMLS CUI [1])
Central Nervous System Involvement Symptomatic | Central Nervous System Involvement untreated
Item
7. have symptomatic or untreated central nervous system (cns) involvement.
boolean
C4050309 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C4050309 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
8. are pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
ARQ 501 Exposure to
Item
9. previous exposure to arq 501.
boolean
C1328233 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
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