ID

27496

Description

Phase II Study of CAP-232 in Patients With Refractory Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00422786

Lien

https://clinicaltrials.gov/show/NCT00422786

Mots-clés

Versions (1)
  1. 18/11/2017 18/11/2017 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

18 novembre 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Carcinoma, Renal Cell NCT00422786

Anglais

Eligibility Carcinoma, Renal Cell NCT00422786

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed stage iv kidney clear cell carcinoma.
Description

Renal Clear Cell Carcinoma TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C3258246
confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
Description

Progressive Disease | Systemic therapy | Standard of Care Quantity

Type de données

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2]
C1515119
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C1265611
measurable disease
Description

Measurable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
age >18 years.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of greater than 3 months.
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
at least 5 years free of any other cancer(s). basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
Description

Cancer Other Free of | Basal cell carcinoma Acceptable | Infiltrating basal cell carcinoma Absent | Sclerosing basal cell carcinoma Absent | Carcinoma in situ of uterine cervix Acceptable

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0332296
UMLS CUI [2,1]
C0007117
UMLS CUI [2,2]
C1879533
UMLS CUI [3,1]
C0334257
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0862888
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0851140
UMLS CUI [5,2]
C1879533
ecog performance status 2 or lower (karnofsky 60%).
Description

ECOG performance status | Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
normal organ and marrow function
Description

Organ function | Bone Marrow function

Type de données

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
adequate contraception prior to study entry and for the duration of study participation.
Description

Contraceptive methods

Type de données

boolean

Alias
UMLS CUI [1]
C0700589
ability to understand and have the willingness to sign a written informed consent document.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
ability to receive central vein access catheter and manage an infusion pump.
Description

Central venous catheter Receive Ability | Infusion Pump Managing Ability

Type de données

boolean

Alias
UMLS CUI [1,1]
C1145640
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0085732
UMLS CUI [2,1]
C0021436
UMLS CUI [2,2]
C1273870
UMLS CUI [2,3]
C0085732
women of child bearing potential must have a negative serum pregnancy test.
Description

Childbearing Potential Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
anti-cancer therapy within 4 weeks prior to entering the study
Description

Cancer treatment

Type de données

boolean

Alias
UMLS CUI [1]
C0920425
investigational agents less than 30 days prior to enrollment in the study.
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
known brain metastases
Description

Metastatic malignant neoplasm to brain

Type de données

boolean

Alias
UMLS CUI [1]
C0220650
history of allergic reactions attributed to compounds of similar composition to cap-232.
Description

Allergic Reaction Compound CAP-232 Similar

Type de données

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C1879913
UMLS CUI [1,4]
C2348205
past or current cancer other than kidney cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, other cancer curatively treated and with no evidence of disease for at least 5 years
Description

Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Cancer Other Disease Absent

Type de données

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C1707251
UMLS CUI [4,4]
C0012634
UMLS CUI [4,5]
C0332197
uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
Description

Comorbidity Uncontrolled Protocol Compliance Limited | Social situation Protocol Compliance Limited

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C0439801
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
breastfeeding
Description

Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0006147
patients previously enrolled into this study and subsequently withdrawn
Description

Study Subject Participation Status | Patient withdrawn from trial

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0422727
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Similar models

Eligibility Carcinoma, Renal Cell NCT00422786

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Renal Clear Cell Carcinoma TNM clinical staging
Item
histologically confirmed stage iv kidney clear cell carcinoma.
boolean
C0279702 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Progressive Disease | Systemic therapy | Standard of Care Quantity
Item
confirmed progressive disease after receiving a previous systemic therapy, including at least one line of standard of care.
boolean
C1335499 (UMLS CUI [1])
C1515119 (UMLS CUI [2])
C2936643 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Age
Item
age >18 years.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 3 months.
boolean
C0023671 (UMLS CUI [1])
Cancer Other Free of | Basal cell carcinoma Acceptable | Infiltrating basal cell carcinoma Absent | Sclerosing basal cell carcinoma Absent | Carcinoma in situ of uterine cervix Acceptable
Item
at least 5 years free of any other cancer(s). basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
boolean
C1707251 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
C0007117 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0334257 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0862888 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0851140 (UMLS CUI [5,1])
C1879533 (UMLS CUI [5,2])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status 2 or lower (karnofsky 60%).
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Organ function | Bone Marrow function
Item
normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Contraceptive methods
Item
adequate contraception prior to study entry and for the duration of study participation.
boolean
C0700589 (UMLS CUI [1])
Informed Consent
Item
ability to understand and have the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Central venous catheter Receive Ability | Infusion Pump Managing Ability
Item
ability to receive central vein access catheter and manage an infusion pump.
boolean
C1145640 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
C0021436 (UMLS CUI [2,1])
C1273870 (UMLS CUI [2,2])
C0085732 (UMLS CUI [2,3])
Childbearing Potential Pregnancy test negative
Item
women of child bearing potential must have a negative serum pregnancy test.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cancer treatment
Item
anti-cancer therapy within 4 weeks prior to entering the study
boolean
C0920425 (UMLS CUI [1])
Investigational New Drugs
Item
investigational agents less than 30 days prior to enrollment in the study.
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastases
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Compound CAP-232 Similar
Item
history of allergic reactions attributed to compounds of similar composition to cap-232.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C1879913 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Cancer Other | Exception Curative treatment Skin carcinoma | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Cancer Other Disease Absent
Item
past or current cancer other than kidney cancer, except for: curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, other cancer curatively treated and with no evidence of disease for at least 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0699893 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C1707251 (UMLS CUI [4,3])
C0012634 (UMLS CUI [4,4])
C0332197 (UMLS CUI [4,5])
Comorbidity Uncontrolled Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled intercurrent illness /social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0748872 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Breast Feeding
Item
breastfeeding
boolean
C0006147 (UMLS CUI [1])
Study Subject Participation Status | Patient withdrawn from trial
Item
patients previously enrolled into this study and subsequently withdrawn
boolean
C2348568 (UMLS CUI [1])
C0422727 (UMLS CUI [2])
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