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])
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])