ID

22059

Description

A Study of 5 Fluorouracil and the Anti-Tumor Activity of ADH300004 and 5 Fluorouracil in Subjects With Incurable Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00264472

Link

https://clinicaltrials.gov/show/NCT00264472

Keywords

Versions (1)
  1. 5/17/17 5/17/17 -
Uploaded on

May 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoplasms NCT00264472

English

Eligibility Neoplasms NCT00264472

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Neoplasms NCT00264472
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
> or = 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
advanced or metastatic solid tumors:
Description

Solid tumour Advanced | Solid tumour metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C1522484
part 1: histologically proven advanced or metastatic solid tumors refractory to standard therapy or for which no standard therapy exists
Description

Solid tumour Advanced | Solid tumour metastatic | Standard therapy refractory | Standard therapy Unavailable

Data type

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0686905
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C1273390
UMLS CUI [3,2]
C0205269
UMLS CUI [4,1]
C1273390
UMLS CUI [4,2]
C0686905
UMLS CUI [5]
C2239176
UMLS CUI [6]
C0007131
UMLS CUI [7]
C0699791
UMLS CUI [8]
C0302592
UMLS CUI [9]
C0600139
UMLS CUI [10]
C0678222
radiologically documented measurable or evaluable (non-measurable) disease
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
adequate performance status and organ function, as evidenced by hematologic and biochemical blood testing
Description

performance status | Organ function | Hematologic Test | Blood Test Biochemical

Data type

boolean

Alias
UMLS CUI [1]
C1518965
UMLS CUI [2]
C0678852
UMLS CUI [3]
C0018941
UMLS CUI [4,1]
C0018941
UMLS CUI [4,2]
C0205474
willing to not receive fluoropyrimidine containing chemotherapy for 8 weeks after the last dose of adh300004 in this study
Description

Chemotherapy Containing Pyrimidine Unwilling | ADH300004

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0034284
UMLS CUI [1,4]
C0558080
UMLS CUI [2]
C1831604
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
cytotoxic chemotherapy, radiotherapy, or investigational drug within 28 days prior to study entry
Description

Cytotoxic Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0013230
non-cytotoxic cancer therapy within 14 days prior to study entry
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
portal hypertension with bleeding esophageal or gastric varices within the past 3 months
Description

Hypertension, Portal | Esophageal bleeding | Gastric Varix

Data type

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0239293
UMLS CUI [3]
C0017145
ascites that is refractory to conservative management
Description

Ascites Conservative therapy refractory

Data type

boolean

Alias
UMLS CUI [1,1]
C0003962
UMLS CUI [1,2]
C0459914
UMLS CUI [1,3]
C0205269
inability to take oral medication
Description

Able to swallow oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
active peptic ulcer disease
Description

Peptic Ulcer

Data type

boolean

Alias
UMLS CUI [1]
C0030920
known hypersensitivity to 5-fu or adh300004
Description

Hypersensitivity Fluorouracil | Hypersensitivity ADH300004

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016360
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1831604
stroke, major surgery, or other major tissue injury within 30 days before study entry
Description

Cerebrovascular accident | major surgery | Tissue injury Major

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0679637
UMLS CUI [3,1]
C2136639
UMLS CUI [3,2]
C0205164
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Similar models

Eligibility Neoplasms NCT00264472

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Neoplasms NCT00264472
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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