ID

35190

Beskrivning

A Phase 1, Dose-Escalation Trial of PT2385 Tablets In Patients With Advanced Clear Cell Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02293980

Länk

https://clinicaltrials.gov/show/NCT02293980

Nyckelord

Versioner (1)
  1. 2019-02-23 2019-02-23 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

23 februari 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility ccRCC NCT02293980

Engelsk

Eligibility ccRCC NCT02293980

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility ccRCC NCT02293980
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
has locally advanced or metastatic ccrcc and has progressed during treatment with at least 1 prior therapeutic regimen
Beskrivning

Clear Cell Renal Cell Carcinoma Advanced Locally | Clear-cell metastatic renal cell carcinoma | Disease Progression | Prior Therapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C2931852
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C1514463
UMLS CUI [4,2]
C1265611
is of age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
has a life expectancy of ≥ 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
has adequate organ function
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
if a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
Beskrivning

Female Sterilization | Postmenopausal state | Gender Contraceptive methods | Gender Partner female Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2]
C0232970
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C0086287
UMLS CUI [4,4]
C0700589
able to swallow oral medications
Beskrivning

Able to swallow Oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
Beskrivning

Metastatic malignant neoplasm to brain Untreated | Leptomeningeal disease | Compression of spinal cord

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0751297
UMLS CUI [3]
C0037926
has failed to recover from the reversible effects of prior anticancer therapy
Beskrivning

Effect Reversible Due to Cancer treatment | Recovery failed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1280500
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0920425
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0231175
has uncontrolled or poorly controlled hypertension
Beskrivning

Uncontrolled hypertension | Poor hypertension control

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0421190
is receiving warfarin anticoagulant therapy or expected to require warfarin
Beskrivning

Warfarin | Anticoagulant therapy | Requirement Warfarin Expected

Datatyp

boolean

Alias
UMLS CUI [1]
C0043031
UMLS CUI [2]
C0150457
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0043031
UMLS CUI [3,3]
C1517001
has had any major cardiovascular event within 6 months prior to study drug administration
Beskrivning

Cardiovascular event Major

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0205164
has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
Beskrivning

Heart Disease | Respiration Disorder | Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0035204
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3840291
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C3843040
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0459471
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C3840291
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0459471
UMLS CUI [6,4]
C0683954
has had major surgery within 4 weeks before first study drug administration
Beskrivning

Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
has known hiv
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
has an active infection requiring systemic treatment
Beskrivning

Communicable Disease Requirement Systemic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1515119
is participating in another therapeutic clinical trial
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Tillbaka till toppen

Similar models

Eligibility ccRCC NCT02293980

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility ccRCC NCT02293980
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Clear Cell Renal Cell Carcinoma Advanced Locally | Clear-cell metastatic renal cell carcinoma | Disease Progression | Prior Therapy Quantity
Item
has locally advanced or metastatic ccrcc and has progressed during treatment with at least 1 prior therapeutic regimen
boolean
C0279702 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C2931852 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
Age
Item
is of age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
has a life expectancy of ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Organ function
Item
has adequate organ function
boolean
C0678852 (UMLS CUI [1])
Female Sterilization | Postmenopausal state | Gender Contraceptive methods | Gender Partner female Contraceptive methods
Item
if a female patient, must be surgically sterile, post-menopausal, or must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration, or if a male patient with a female partner, must agree to use physician-approved method of birth control during the study and for a minimum of 30 days after the last study drug administration
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0086287 (UMLS CUI [4,3])
C0700589 (UMLS CUI [4,4])
Able to swallow Oral medication
Item
able to swallow oral medications
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Untreated | Leptomeningeal disease | Compression of spinal cord
Item
has a history of untreated brain metastasis or history of leptomeningeal disease or spinal cord compression
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0751297 (UMLS CUI [2])
C0037926 (UMLS CUI [3])
Effect Reversible Due to Cancer treatment | Recovery failed
Item
has failed to recover from the reversible effects of prior anticancer therapy
boolean
C1280500 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0920425 (UMLS CUI [1,4])
C2004454 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Uncontrolled hypertension | Poor hypertension control
Item
has uncontrolled or poorly controlled hypertension
boolean
C1868885 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
Warfarin | Anticoagulant therapy | Requirement Warfarin Expected
Item
is receiving warfarin anticoagulant therapy or expected to require warfarin
boolean
C0043031 (UMLS CUI [1])
C0150457 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0043031 (UMLS CUI [3,2])
C1517001 (UMLS CUI [3,3])
Cardiovascular event Major
Item
has had any major cardiovascular event within 6 months prior to study drug administration
boolean
C1320716 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
Heart Disease | Respiration Disorder | Other medical condition Interferes with Study Subject Participation Status | Mental condition Interferes with Study Subject Participation Status | Other medical condition Interferes with Interpretation Research results | Mental condition Interferes with Interpretation Research results
Item
has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results
boolean
C0018799 (UMLS CUI [1])
C0035204 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C3843040 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0459471 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3840291 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0459471 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Major surgery
Item
has had major surgery within 4 weeks before first study drug administration
boolean
C0679637 (UMLS CUI [1])
HIV Infection
Item
has known hiv
boolean
C0019693 (UMLS CUI [1])
Communicable Disease Requirement Systemic therapy
Item
has an active infection requiring systemic treatment
boolean
C0009450 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1515119 (UMLS CUI [1,3])
Study Subject Participation Status
Item
is participating in another therapeutic clinical trial
boolean
C2348568 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial