ID

43900

Description

A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01356628

Link

https://clinicaltrials.gov/show/NCT01356628

Keywords

Versions (2)
  1. 6/28/16 6/28/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Advanced Hepatocellular Carcinoma NCT01356628

English

Eligibility Advanced Hepatocellular Carcinoma NCT01356628

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, age > or = 18 years with hcc refractory to currently available therapies.
Description

hcc refractory to currently available therapies

Data type

boolean

Alias
UMLS CUI [1,1]
C2239176
UMLS CUI [1,2]
C0205269
documented hcc by at least 2 out of 3 mentioned criteria and evidence of non-resectability by a multidisciplinary team:
Description

hcc

Data type

boolean

Alias
UMLS CUI [1]
C2239176
radiological - mri with arterial enhancement and rapid venous washout b. biopsy c. serum alpha-fetoprotein level > or = 200
Description

radiological - mri , serum alpha-fetoprotein level hrr

Data type

boolean

Alias
UMLS CUI [1]
C0024485
UMLS CUI [2]
C1287375
positive staining for rb-function on tumor biopsy
Description

rb-function on tumor biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0035335
subject must be able to give written informed consent and be able to follow protocol requirements
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
life expectancy greater than 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
child's-pugh class a or b
Description

child's-pugh class a or b

Data type

boolean

ecog performance status of < or = 2
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
if female of childbearing potential must have negative pregnancy test at screening and may not be breast-feeding
Description

negative pregnancy test

Data type

boolean

Alias
UMLS CUI [1]
C0427780
females of child-bearing potential (< one year post-menopausal with documented fsh greater than 30 iu/l or surgically not sterile), must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, condom, diaphragm with spermicidal, cervical cap, abstinence or sterile sex partner) from the time informed consent is signed through follow-up. males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up.
Description

contraceptives

Data type

boolean

Alias
UMLS CUI [1]
C0009905
no other active malignancy requiring treatment in the last 3 years other than adequately treated non-melanomatous skin cancer, adequately treated cervical carcinoma in-situ, superficial adequately treated bladder cancer or prostatic intraepithelial neoplasia without evidence of prostate cancer.
Description

active malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
adequate bone marrow, liver and renal function as assessed by the following:
Description

adequate organ function

Data type

boolean

Alias
UMLS CUI [1]
C1254358
hemoglobin > or = 8 g/dl b. wbc > or = 4,000/ul c. absolute neutrophil count > or = 1,500/ul d. platelets > or = 75,000/ul e. total bilirubin < or = 1.5 times uln f. alt and ast < or = 5 times uln g. creatinine < or = 1.5 times uln h. albumin > or = 2.5 mg/dl
Description

hemoglobin, absolute neutrophil count, platelets

Data type

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0019046
subjects who have received previous radiotherapy, loco-regional, or systemic therapy are eligible. a minimum interval of 4 weeks since the last anti-cancer treatment of any kind is required.
Description

radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
subjects with brain metastases or a history of previously treated brain metastasis are eligible but must:
Description

brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
have been treated by surgery or stereotactic radiosurgery (srs) at least 4 weeks prior to enrollment b. and have a baseline mri or ct that shows no evidence of active intercranial disease c. and be off steroids for at least 1 week prior to study enrollment
Description

stereotactic radiosurgery

Data type

boolean

Alias
UMLS CUI [1]
C0085203
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any concurrent active malignancy requiring treatment (other than basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, or other malignancies curatively treated > 3 years prior to study entry)
Description

concurrent active malignancy

Data type

boolean

Alias
UMLS CUI [1]
C0006826
history of severe cardiovascular disease within the last 12 months: symptomatic congestive heart failure, myocardial infarction, coronary artery disease (cad), life threatening arrhythmias, uncontrolled hypertension
Description

cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
renal failure requiring hemo- or peritoneal dialysis
Description

renal failure

Data type

boolean

Alias
UMLS CUI [1]
C1533077
unstable systemic diseases or active uncontrolled infection
Description

systemic diseases or active uncontrolled infection

Data type

boolean

Alias
UMLS CUI [1]
C0442893
UMLS CUI [2]
C0009450
known history of hiv infection
Description

hiv infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
clinically significant gastrointestinal bleeding within 30 days prior to study entry
Description

gastrointestinal bleeding

Data type

boolean

Alias
UMLS CUI [1]
C0017181
major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry
Description

major surgery, open biopsy or significant traumatic injury

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0184922
UMLS CUI [3]
C3263723
child's-pugh class c
Description

child's-pugh class c

Data type

boolean

Alias
UMLS CUI [1]
C3831115
any malabsorption problem that, in the investigator's opinion, would prevent adequate absorption of the study drug
Description

malabsorption

Data type

boolean

Alias
UMLS CUI [1]
C3714745
presence of any other medical complications that in the investigator's opinion, suggests a survival of < 3 months
Description

medical complication

Data type

boolean

Alias
UMLS CUI [1]
C0009566
substance abuse, or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Description

interfere with the patient's participation in the study or evaluation of the study results

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
patient inability to swallow oral medications
Description

swallow oral medications

Data type

boolean

Alias
UMLS CUI [1]
C0175795
any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
Description

jeopardize the safety of the patient and his/her compliance in the study

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
pregnant or breast-feeding patients
Description

pregnant or breast-feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
being of reproductive potential and unable or unwilling to practice an effective contraceptive method
Description

contraceptive method

Data type

boolean

Alias
UMLS CUI [1]
C0700589
lack of positive staining for rb-function on tumor biopsy
Description

lack of positive staining for rb-function on tumor biopsy

Data type

boolean

Alias
UMLS CUI [1]
C0079424
UMLS CUI [2]
C0005558
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Similar models

Eligibility Advanced Hepatocellular Carcinoma NCT01356628

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
hcc refractory to currently available therapies
Item
male or female, age > or = 18 years with hcc refractory to currently available therapies.
boolean
C2239176 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
hcc
Item
documented hcc by at least 2 out of 3 mentioned criteria and evidence of non-resectability by a multidisciplinary team:
boolean
C2239176 (UMLS CUI [1])
radiological - mri , serum alpha-fetoprotein level hrr
Item
radiological - mri with arterial enhancement and rapid venous washout b. biopsy c. serum alpha-fetoprotein level > or = 200
boolean
C0024485 (UMLS CUI [1])
C1287375 (UMLS CUI [2])
rb-function on tumor biopsy
Item
positive staining for rb-function on tumor biopsy
boolean
C0035335 (UMLS CUI [1])
informed consent
Item
subject must be able to give written informed consent and be able to follow protocol requirements
boolean
C0021430 (UMLS CUI [1])
life expectancy
Item
life expectancy greater than 3 months
boolean
C0023671 (UMLS CUI [1])
child's-pugh class a or b
Item
child's-pugh class a or b
boolean
ecog
Item
ecog performance status of < or = 2
boolean
C1520224 (UMLS CUI [1])
negative pregnancy test
Item
if female of childbearing potential must have negative pregnancy test at screening and may not be breast-feeding
boolean
C0427780 (UMLS CUI [1])
contraceptives
Item
females of child-bearing potential (< one year post-menopausal with documented fsh greater than 30 iu/l or surgically not sterile), must agree to practice an effective method of avoiding pregnancy (including oral or implanted contraceptives, intrauterine device, condom, diaphragm with spermicidal, cervical cap, abstinence or sterile sex partner) from the time informed consent is signed through follow-up. males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up.
boolean
C0009905 (UMLS CUI [1])
active malignancy
Item
no other active malignancy requiring treatment in the last 3 years other than adequately treated non-melanomatous skin cancer, adequately treated cervical carcinoma in-situ, superficial adequately treated bladder cancer or prostatic intraepithelial neoplasia without evidence of prostate cancer.
boolean
C0006826 (UMLS CUI [1])
adequate organ function
Item
adequate bone marrow, liver and renal function as assessed by the following:
boolean
C1254358 (UMLS CUI [1])
hemoglobin, absolute neutrophil count, platelets
Item
hemoglobin > or = 8 g/dl b. wbc > or = 4,000/ul c. absolute neutrophil count > or = 1,500/ul d. platelets > or = 75,000/ul e. total bilirubin < or = 1.5 times uln f. alt and ast < or = 5 times uln g. creatinine < or = 1.5 times uln h. albumin > or = 2.5 mg/dl
boolean
C0005821 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0019046 (UMLS CUI [3])
radiotherapy
Item
subjects who have received previous radiotherapy, loco-regional, or systemic therapy are eligible. a minimum interval of 4 weeks since the last anti-cancer treatment of any kind is required.
boolean
C1522449 (UMLS CUI [1])
brain metastases
Item
subjects with brain metastases or a history of previously treated brain metastasis are eligible but must:
boolean
C0220650 (UMLS CUI [1])
stereotactic radiosurgery
Item
have been treated by surgery or stereotactic radiosurgery (srs) at least 4 weeks prior to enrollment b. and have a baseline mri or ct that shows no evidence of active intercranial disease c. and be off steroids for at least 1 week prior to study enrollment
boolean
C0085203 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
concurrent active malignancy
Item
any concurrent active malignancy requiring treatment (other than basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, or other malignancies curatively treated > 3 years prior to study entry)
boolean
C0006826 (UMLS CUI [1])
cardiovascular disease
Item
history of severe cardiovascular disease within the last 12 months: symptomatic congestive heart failure, myocardial infarction, coronary artery disease (cad), life threatening arrhythmias, uncontrolled hypertension
boolean
C0007222 (UMLS CUI [1])
renal failure
Item
renal failure requiring hemo- or peritoneal dialysis
boolean
C1533077 (UMLS CUI [1])
systemic diseases or active uncontrolled infection
Item
unstable systemic diseases or active uncontrolled infection
boolean
C0442893 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
hiv infection
Item
known history of hiv infection
boolean
C0019693 (UMLS CUI [1])
gastrointestinal bleeding
Item
clinically significant gastrointestinal bleeding within 30 days prior to study entry
boolean
C0017181 (UMLS CUI [1])
major surgery, open biopsy or significant traumatic injury
Item
major surgery, open biopsy or significant traumatic injury within 4 weeks prior to study entry
boolean
C0679637 (UMLS CUI [1])
C0184922 (UMLS CUI [2])
C3263723 (UMLS CUI [3])
child's-pugh class c
Item
child's-pugh class c
boolean
C3831115 (UMLS CUI [1])
malabsorption
Item
any malabsorption problem that, in the investigator's opinion, would prevent adequate absorption of the study drug
boolean
C3714745 (UMLS CUI [1])
medical complication
Item
presence of any other medical complications that in the investigator's opinion, suggests a survival of < 3 months
boolean
C0009566 (UMLS CUI [1])
interfere with the patient's participation in the study or evaluation of the study results
Item
substance abuse, or medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
swallow oral medications
Item
patient inability to swallow oral medications
boolean
C0175795 (UMLS CUI [1])
jeopardize the safety of the patient and his/her compliance in the study
Item
any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
pregnant or breast-feeding
Item
pregnant or breast-feeding patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
contraceptive method
Item
being of reproductive potential and unable or unwilling to practice an effective contraceptive method
boolean
C0700589 (UMLS CUI [1])
lack of positive staining for rb-function on tumor biopsy
Item
lack of positive staining for rb-function on tumor biopsy
boolean
C0079424 (UMLS CUI [1])
C0005558 (UMLS CUI [2])
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