Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
> or = 18 years of age
boolean
C0001779 (UMLS CUI [1])
Solid tumour Advanced | Solid tumour metastatic
Item
advanced or metastatic solid tumors:
boolean
C0280100 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Solid tumour Advanced | Solid tumour metastatic | Standard therapy refractory | Standard therapy Unavailable
Item
part 1: histologically proven advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists
boolean
C0280100 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
Solid tumour Advanced | Solid tumour metastatic | Curative treatment refractory | Curative treatment Unavailable | Liver carcinoma | Non-Small Cell Lung Carcinoma | Stomach Carcinoma | Cervix carcinoma | Prostate carcinoma | Breast Carcinoma
Item
part 2: histologically proven advanced and/or metastatic solid tumor of one of the following 6 histologies, that is refractory to standard curative therapy or for which no curative therapy exists: hcc, nsclc, gastric cancer, cervical cancer, prostate cancer, and breast cancer
boolean
C0280100 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C1273390 (UMLS CUI [3,1])
C0205269 (UMLS CUI [3,2])
C1273390 (UMLS CUI [4,1])
C0686905 (UMLS CUI [4,2])
C2239176 (UMLS CUI [5])
C0007131 (UMLS CUI [6])
C0699791 (UMLS CUI [7])
C0302592 (UMLS CUI [8])
C0600139 (UMLS CUI [9])
C0678222 (UMLS CUI [10])
Measurable Disease | Evaluable Disease
Item
radiologically documented measurable or evaluable (non-measurable) disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
performance status | Organ function | Hematologic Test | Blood Test Biochemical
Item
adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
boolean
C1518965 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
C0018941 (UMLS CUI [4,1])
C0205474 (UMLS CUI [4,2])
Chemotherapy Containing Pyrimidine Unwilling | ADH300004
Item
willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of adh300004 in this study
boolean
C0392920 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0034284 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C1831604 (UMLS CUI [2])
Cytotoxic Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry
boolean
C0677881 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
cancer treatment
Item
non-cytotoxic cancer therapy within 14 days prior to study entry
boolean
C0920425 (UMLS CUI [1])
Hypertension, Portal | Esophageal bleeding | Gastric Varix
Item
portal hypertension with bleeding esophageal or gastric varices within the past 3 months
boolean
C0020541 (UMLS CUI [1])
C0239293 (UMLS CUI [2])
C0017145 (UMLS CUI [3])
Ascites Conservative therapy refractory
Item
ascites that is refractory to conservative management
boolean
C0003962 (UMLS CUI [1,1])
C0459914 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Able to swallow oral medication
Item
inability to take oral medication
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Peptic Ulcer
Item
active peptic ulcer disease
boolean
C0030920 (UMLS CUI [1])
Hypersensitivity Fluorouracil | Hypersensitivity ADH300004
Item
known hypersensitivity to 5-fu or adh300004
boolean
C0020517 (UMLS CUI [1,1])
C0016360 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1831604 (UMLS CUI [2,2])
Cerebrovascular accident | major surgery | Tissue injury Major
Item
stroke, major surgery, or other major tissue injury within 30 days before study entry
boolean
C0038454 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C2136639 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])