ID

25106

Description

A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00600535

Lien

https://clinicaltrials.gov/show/NCT00600535

Mots-clés

Versions (1)
  1. 26/08/2017 26/08/2017 -
Téléchargé le

26 août 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Prostate Neoplasms NCT00600535

Anglais

Eligibility Prostate Neoplasms NCT00600535

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men with histologically, cytologically, or biochemically confirmed adenocarcinoma of the prostate
Description

Adenocarcinoma of prostate

Type de données

boolean

Alias
UMLS CUI [1]
C0007112
on-going androgen deprivation with serum testosterone <50 ng/dl (<2.0nmol/l)
Description

Antiandrogen therapy | Serum testosterone measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0279492
UMLS CUI [2]
C0428413
serum potassium >=3.5 mmol/l
Description

Serum potassium measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0302353
eastern cooperative oncology group (ecog) performance status score <2 (karnofsky performance status >=50%)
Description

ECOG performance status | Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
no history of adrenal insufficiency or hyperaldosteronism
Description

Adrenal gland hypofunction Absent | Hyperaldosteronism Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001623
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0020428
UMLS CUI [2,2]
C0332197
any acute toxicities of prior chemotherapy, radiotherapy have resolved to a nci ctcae (version 3.0) grade of <=1 (chemotherapy induced alopecia and grade 2 neuropathy are excluded from this consideration)
Description

Toxicity Due to Prior Chemotherapy | Toxicity Due to Prior radiation therapy | Patient condition resolved CTCAE Grades | Alopecia post chemotherapy Excluded | Neuropathy CTCAE Grades Excluded

Type de données

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C1514457
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0279134
UMLS CUI [3,1]
C0438113
UMLS CUI [3,2]
C1516728
UMLS CUI [4,1]
C3267164
UMLS CUI [4,2]
C2828389
UMLS CUI [5,1]
C0442874
UMLS CUI [5,2]
C1516728
UMLS CUI [5,3]
C2828389
no radiotherapy, chemotherapy, or immunotherapy within 30 days of administration of the study drug 1 (sd1) on day 1
Description

Therapeutic radiology procedure Absent | Chemotherapy Absent | Immunotherapy Absent

Type de données

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0332197
no surgery or local prostatic intervention within 28 days of the first dose (any clinically relevant sequelae from the surgery must have resolved prior to sd1 on day 1)
Description

Operative Surgical Procedures Absent | Intervention Prostatic Local Absent | Operative Surgical Procedures Sequelae Resolved

Type de données

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1522721
UMLS CUI [2,3]
C0205276
UMLS CUI [2,4]
C0332197
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C0243088
UMLS CUI [3,3]
C1514893
agrees to protocol-defined use of effective contraception
Description

Contraceptive methods Agree

Type de données

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3641827
life expectancy >12 weeks
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
active or uncontrolled autoimmune disease that may require corticosteroid therapy
Description

Autoimmune Disease | Autoimmune Disease Uncontrolled | Steroid therapy Patient need for

Type de données

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0004364
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0149783
UMLS CUI [3,2]
C0686904
serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
Description

Comorbidity Serious | Comorbidity Uncontrolled | Communicable Disease | Communicable Disease Uncontrolled

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0009450
UMLS CUI [4,1]
C0009450
UMLS CUI [4,2]
C0205318
uncontrolled hypertension
Description

Uncontrolled hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C1868885
protocol-defined laboratory values
Description

Laboratory Results Study Protocol

Type de données

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2348563
clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease (patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)
Description

Heart Disease Clinical Significance | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Heart Disease New York Heart Association Classification | Atherosclerosis Requirement Coronary Artery Bypass Surgery | Atherosclerosis Requirement Peripheral arterial bypass

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205082
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0018799
UMLS CUI [5,2]
C1275491
UMLS CUI [6,1]
C0004153
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0010055
UMLS CUI [7,1]
C0004153
UMLS CUI [7,2]
C1514873
UMLS CUI [7,3]
C0190961
other malignancy within the previous 5-years other than basal cell or squamous cell carcinomas of skin with a >30% probability of recurrence within 12 months
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Recurrence Probability Percentage

Type de données

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C2825055
UMLS CUI [4,2]
C0033204
UMLS CUI [4,3]
C0439165
history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication
Description

Gastrointestinal Disease Interferes with Absorption Investigational New Drugs | Gastrointestinal Surgical Procedure Interferes with Absorption Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C0013230
UMLS CUI [2,1]
C0524722
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C0013230
condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Description

Condition At risk Patient | Condition Interferes with Research results | Condition Interferes with Study Subject Participation Status | Situation At risk Patient | Situation Interferes with Research results | Situation Interferes with Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0030705
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0030705
UMLS CUI [5,1]
C0748872
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0683954
UMLS CUI [6,1]
C0748872
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
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Similar models

Eligibility Prostate Neoplasms NCT00600535

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Adenocarcinoma of prostate
Item
men with histologically, cytologically, or biochemically confirmed adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Antiandrogen therapy | Serum testosterone measurement
Item
on-going androgen deprivation with serum testosterone <50 ng/dl (<2.0nmol/l)
boolean
C0279492 (UMLS CUI [1])
C0428413 (UMLS CUI [2])
Serum potassium measurement
Item
serum potassium >=3.5 mmol/l
boolean
C0302353 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
eastern cooperative oncology group (ecog) performance status score <2 (karnofsky performance status >=50%)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Adrenal gland hypofunction Absent | Hyperaldosteronism Absent
Item
no history of adrenal insufficiency or hyperaldosteronism
boolean
C0001623 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0020428 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Toxicity Due to Prior Chemotherapy | Toxicity Due to Prior radiation therapy | Patient condition resolved CTCAE Grades | Alopecia post chemotherapy Excluded | Neuropathy CTCAE Grades Excluded
Item
any acute toxicities of prior chemotherapy, radiotherapy have resolved to a nci ctcae (version 3.0) grade of <=1 (chemotherapy induced alopecia and grade 2 neuropathy are excluded from this consideration)
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C1514457 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0279134 (UMLS CUI [2,3])
C0438113 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C3267164 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
C0442874 (UMLS CUI [5,1])
C1516728 (UMLS CUI [5,2])
C2828389 (UMLS CUI [5,3])
Therapeutic radiology procedure Absent | Chemotherapy Absent | Immunotherapy Absent
Item
no radiotherapy, chemotherapy, or immunotherapy within 30 days of administration of the study drug 1 (sd1) on day 1
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Operative Surgical Procedures Absent | Intervention Prostatic Local Absent | Operative Surgical Procedures Sequelae Resolved
Item
no surgery or local prostatic intervention within 28 days of the first dose (any clinically relevant sequelae from the surgery must have resolved prior to sd1 on day 1)
boolean
C0543467 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C1522721 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C0332197 (UMLS CUI [2,4])
C0543467 (UMLS CUI [3,1])
C0243088 (UMLS CUI [3,2])
C1514893 (UMLS CUI [3,3])
Contraceptive methods Agree
Item
agrees to protocol-defined use of effective contraception
boolean
C0700589 (UMLS CUI [1,1])
C3641827 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy >12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease | Autoimmune Disease Uncontrolled | Steroid therapy Patient need for
Item
active or uncontrolled autoimmune disease that may require corticosteroid therapy
boolean
C0004364 (UMLS CUI [1])
C0004364 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0149783 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Comorbidity Serious | Comorbidity Uncontrolled | Communicable Disease | Communicable Disease Uncontrolled
Item
serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3])
C0009450 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Laboratory Results Study Protocol
Item
protocol-defined laboratory values
boolean
C1254595 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Heart Disease Clinical Significance | Myocardial Infarction | Angina Pectoris Severe | Angina, Unstable | Heart Disease New York Heart Association Classification | Atherosclerosis Requirement Coronary Artery Bypass Surgery | Atherosclerosis Requirement Peripheral arterial bypass
Item
clinically significant heart disease as evidenced by a myocardial infarction in the past 12 months, severe or unstable angina, or new york heart association (nyha) class iii or iv heart disease (patients with a history of atherosclerotic vascular disease requiring coronary or peripheral artery bypass surgery may be enrolled provided the surgery occurred at least 2 years prior to enrollment and after consultation with a cardiologist to insure that the disease is stable)
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0018799 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0004153 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0010055 (UMLS CUI [6,3])
C0004153 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
C0190961 (UMLS CUI [7,3])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Recurrence Probability Percentage
Item
other malignancy within the previous 5-years other than basal cell or squamous cell carcinomas of skin with a >30% probability of recurrence within 12 months
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C2825055 (UMLS CUI [4,1])
C0033204 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])
Gastrointestinal Disease Interferes with Absorption Investigational New Drugs | Gastrointestinal Surgical Procedure Interferes with Absorption Investigational New Drugs
Item
history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study medication
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C0013230 (UMLS CUI [1,4])
C0524722 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
Condition At risk Patient | Condition Interferes with Research results | Condition Interferes with Study Subject Participation Status | Situation At risk Patient | Situation Interferes with Research results | Situation Interferes with Study Subject Participation Status
Item
condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0030705 (UMLS CUI [4,3])
C0748872 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])
C0748872 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
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