ID

38520

Description

Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy; ODM derived from: https://clinicaltrials.gov/show/NCT01856101

Link

https://clinicaltrials.gov/show/NCT01856101

Keywords

Versions (1)
  1. 10/23/19 10/23/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 23, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Carcinoma Transitional Cell NCT01856101

English

Eligibility Carcinoma Transitional Cell NCT01856101

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with histologically- or cytologically-confirmed locally advanced or metastatic tcc not amenable to curative surgery or radiation.
Description

Transitional Cell Carcinoma Advanced Locally | Transitional cell carcinoma metastatic | Transitional Cell Carcinoma Inappropriate Curative Surgery | Transitional Cell Carcinoma Inappropriate Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0007138
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2]
C3160869
UMLS CUI [3,1]
C0007138
UMLS CUI [3,2]
C1548788
UMLS CUI [3,3]
C1511562
UMLS CUI [4,1]
C0007138
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1522449
2. documented disease progression (according recist 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
Description

Disease Progression | Status post First line treatment Platinum-Based | Neoadjuvant Therapy | Adjuvant therapy | Palliative Care

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C1514162
UMLS CUI [3]
C0600558
UMLS CUI [4]
C0677850
UMLS CUI [5]
C0030231
3. an interval of >4 weeks since last anticancer treatment.
Description

Interval Since Cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0920425
4. archival paraffin-embedded tumor tissue (block or at least 20 unstained slides) of the primary tumor and/or metastases. the most recent archival tissue is mandatory. recidive of the disease should lead to perform if possible novel biopsies, as major oncogenic differences are found between primary tumor and secondary lesions.
Description

Paraffin Embedded Tissue Block Primary tumor | Paraffin embedded slide Unstained Quantity Primary tumor | Paraffin Embedded Tissue Block Neoplasm Metastasis | Paraffin embedded slide Unstained Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C1519524
UMLS CUI [1,2]
C1533157
UMLS CUI [1,3]
C0677930
UMLS CUI [2,1]
C4039662
UMLS CUI [2,2]
C1883469
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0677930
UMLS CUI [3,1]
C1519524
UMLS CUI [3,2]
C1533157
UMLS CUI [3,3]
C0027627
UMLS CUI [4,1]
C4039662
UMLS CUI [4,2]
C1883469
UMLS CUI [4,3]
C1265611
UMLS CUI [4,4]
C0027627
5. at least one measurable lesion by mri or ct-scan
Description

Measurable lesion Quantity MRI | Measurable lesion Quantity CT

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0024485
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0040405
6. ecog performance status 0-1, in stable medical condition
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
7. patients must have adequate organ function: hemoglobin ≥ 9 g/100 ml, neutrophils ≥
Description

Organ function | Hemoglobin measurement | Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0200633
1,000/mm3, platelets ≥ 100,000/mm, inr ≤ 1.5, total serum bilirubin ≤ 1.5 x uln, alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 x uln (or <5.0 x uln if hepatic metastases are present), creatinine £1.5 x uln, fasting plasma glucose <140mg/dl, hba1c < 8%.
Description

Platelet Count measurement | International Normalized Ratio | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine measurement, serum | Plasma fasting glucose measurement | Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2]
C0525032
UMLS CUI [3]
C1278039
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0494165
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0583513
UMLS CUI [9]
C0474680
8. patients must be over 18 years old and able to give written informed consent.
Description

Age | Informed Consent Able

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0085732
9. signed informed consent prior to beginning protocol specific procedure
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. non- tcc bladder cancer
Description

Malignant neoplasm of urinary bladder | Exception Transitional Cell Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0005684
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007138
2. more than 2 prior chemotherapy regimens given for palliation.
Description

Prior Chemotherapy Quantity Disease palliation

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0679251
3. concurrent malignancy or previous malignancy in the last 3 years prior to start the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer)
Description

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1522326
4. patient with active uncontrolled or symptomatic central nervous system (cns metastases).
Description

CNS metastases Uncontrolled | CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0686377
UMLS CUI [2,2]
C0231220
5. significant active cardiac disease including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias.
Description

Heart Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C1868885
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C0205404
6. other uncontrolled medical condition (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
Description

Other medical condition Uncontrolled | Communicable Diseases Requirement Antibiotics | Blood Coagulation Disorders | Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0003232
UMLS CUI [3]
C0005779
UMLS CUI [4]
C0421258
7. other concomitant anticancer therapy.
Description

Cancer treatment Other

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205394
8. previous therapy with pi3k and/or mtor inhibitors (sirolimus, temsirolimus, everolimus)
Description

PI3K Inhibitor | mTOR Inhibitor | Sirolimus | temsirolimus | everolimus

Data type

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2]
C2746052
UMLS CUI [3]
C0072980
UMLS CUI [4]
C1707080
UMLS CUI [5]
C0541315
9. concomitant drugs such as coumarin and warfarin, and drugs known to induce torsade de pointe, drugs known to be moderate or strong inhibitors or inducers of cyp3a4
Description

Coumarin | Warfarin | Pharmaceutical Preparations Inducing Torsades de Pointes | CYP3A4 Inhibitors Moderate | CYP3A4 Inducers Moderate | CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong

Data type

boolean

Alias
UMLS CUI [1]
C0010206
UMLS CUI [2]
C0043031
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0205263
UMLS CUI [3,3]
C0040479
UMLS CUI [4,1]
C3850053
UMLS CUI [4,2]
C0205081
UMLS CUI [5,1]
C3850041
UMLS CUI [5,2]
C0205081
UMLS CUI [6,1]
C3850053
UMLS CUI [6,2]
C0442821
UMLS CUI [7,1]
C3850041
UMLS CUI [7,2]
C0442821
10. pregnancy or risk of pregnancy.
Description

Pregnancy | At risk Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C1444641
UMLS CUI [2,2]
C0032961
Back to the top of the page

Similar models

Eligibility Carcinoma Transitional Cell NCT01856101

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Transitional Cell Carcinoma Advanced Locally | Transitional cell carcinoma metastatic | Transitional Cell Carcinoma Inappropriate Curative Surgery | Transitional Cell Carcinoma Inappropriate Therapeutic radiology procedure
Item
1. patients with histologically- or cytologically-confirmed locally advanced or metastatic tcc not amenable to curative surgery or radiation.
boolean
C0007138 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C3160869 (UMLS CUI [2])
C0007138 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1511562 (UMLS CUI [3,3])
C0007138 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1522449 (UMLS CUI [4,3])
Disease Progression | Status post First line treatment Platinum-Based | Neoadjuvant Therapy | Adjuvant therapy | Palliative Care
Item
2. documented disease progression (according recist 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C1514162 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3])
C0677850 (UMLS CUI [4])
C0030231 (UMLS CUI [5])
Interval Since Cancer treatment
Item
3. an interval of >4 weeks since last anticancer treatment.
boolean
C1272706 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Paraffin Embedded Tissue Block Primary tumor | Paraffin embedded slide Unstained Quantity Primary tumor | Paraffin Embedded Tissue Block Neoplasm Metastasis | Paraffin embedded slide Unstained Quantity Neoplasm Metastasis
Item
4. archival paraffin-embedded tumor tissue (block or at least 20 unstained slides) of the primary tumor and/or metastases. the most recent archival tissue is mandatory. recidive of the disease should lead to perform if possible novel biopsies, as major oncogenic differences are found between primary tumor and secondary lesions.
boolean
C1519524 (UMLS CUI [1,1])
C1533157 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C4039662 (UMLS CUI [2,1])
C1883469 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0677930 (UMLS CUI [2,4])
C1519524 (UMLS CUI [3,1])
C1533157 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C4039662 (UMLS CUI [4,1])
C1883469 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0027627 (UMLS CUI [4,4])
Measurable lesion Quantity MRI | Measurable lesion Quantity CT
Item
5. at least one measurable lesion by mri or ct-scan
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0040405 (UMLS CUI [2,3])
ECOG performance status
Item
6. ecog performance status 0-1, in stable medical condition
boolean
C1520224 (UMLS CUI [1])
Organ function | Hemoglobin measurement | Neutrophil count
Item
7. patients must have adequate organ function: hemoglobin ≥ 9 g/100 ml, neutrophils ≥
boolean
C0678852 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
Platelet Count measurement | International Normalized Ratio | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver | Creatinine measurement, serum | Plasma fasting glucose measurement | Hemoglobin A1c measurement
Item
1,000/mm3, platelets ≥ 100,000/mm, inr ≤ 1.5, total serum bilirubin ≤ 1.5 x uln, alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 x uln (or <5.0 x uln if hepatic metastases are present), creatinine £1.5 x uln, fasting plasma glucose <140mg/dl, hba1c < 8%.
boolean
C0032181 (UMLS CUI [1])
C0525032 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0494165 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0583513 (UMLS CUI [8])
C0474680 (UMLS CUI [9])
Age | Informed Consent Able
Item
8. patients must be over 18 years old and able to give written informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
Informed Consent
Item
9. signed informed consent prior to beginning protocol specific procedure
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant neoplasm of urinary bladder | Exception Transitional Cell Carcinoma
Item
1. non- tcc bladder cancer
boolean
C0005684 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007138 (UMLS CUI [2,2])
Prior Chemotherapy Quantity Disease palliation
Item
2. more than 2 prior chemotherapy regimens given for palliation.
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679251 (UMLS CUI [1,3])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Skin carcinoma Treated
Item
3. concurrent malignancy or previous malignancy in the last 3 years prior to start the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer)
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
CNS metastases Uncontrolled | CNS metastases Symptomatic
Item
4. patient with active uncontrolled or symptomatic central nervous system (cns metastases).
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Heart Disease | Uncontrolled hypertension | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Serious
Item
5. significant active cardiac disease including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias.
boolean
C0018799 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C0205404 (UMLS CUI [6,2])
Other medical condition Uncontrolled | Communicable Diseases Requirement Antibiotics | Blood Coagulation Disorders | Diabetic - poor control
Item
6. other uncontrolled medical condition (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes …)
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C0005779 (UMLS CUI [3])
C0421258 (UMLS CUI [4])
Cancer treatment Other
Item
7. other concomitant anticancer therapy.
boolean
C0920425 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
PI3K Inhibitor | mTOR Inhibitor | Sirolimus | temsirolimus | everolimus
Item
8. previous therapy with pi3k and/or mtor inhibitors (sirolimus, temsirolimus, everolimus)
boolean
C1519050 (UMLS CUI [1])
C2746052 (UMLS CUI [2])
C0072980 (UMLS CUI [3])
C1707080 (UMLS CUI [4])
C0541315 (UMLS CUI [5])
Coumarin | Warfarin | Pharmaceutical Preparations Inducing Torsades de Pointes | CYP3A4 Inhibitors Moderate | CYP3A4 Inducers Moderate | CYP3A4 Inhibitors Strong | CYP3A4 Inducers Strong
Item
9. concomitant drugs such as coumarin and warfarin, and drugs known to induce torsade de pointe, drugs known to be moderate or strong inhibitors or inducers of cyp3a4
boolean
C0010206 (UMLS CUI [1])
C0043031 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0205263 (UMLS CUI [3,2])
C0040479 (UMLS CUI [3,3])
C3850053 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C3850041 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C3850053 (UMLS CUI [6,1])
C0442821 (UMLS CUI [6,2])
C3850041 (UMLS CUI [7,1])
C0442821 (UMLS CUI [7,2])
Pregnancy | At risk Pregnancy
Item
10. pregnancy or risk of pregnancy.
boolean
C0032961 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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