ID

36143

Description

A Phase I/II, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma. ODM derived from: https://clinicaltrials.gov/show/NCT01661179

Link

https://clinicaltrials.gov/show/NCT01661179

Keywords

Versions (2)
  1. 4/17/19 4/17/19 -
  2. 4/17/19 4/17/19 -
Copyright Holder

Genzyme Sanofi Company

Uploaded on

April 17, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
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.

Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma NCT01661179

English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
Written consent from female or male japanese patients aged 20 years and over.
Description

Age and consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
UMLS CUI [3]
C1556094
Patient with previous diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic medullary thyroid carcinoma(mtc).
Description

Diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C1833921
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C0677984
UMLS CUI [2,1]
C1710166
UMLS CUI [2,2]
C1519810
UMLS CUI [2,3]
C0677984
UMLS CUI [3,1]
C1833921
UMLS CUI [3,2]
C1519810
UMLS CUI [3,3]
C0027627
UMLS CUI [4,1]
C1710166
UMLS CUI [4,2]
C1519810
UMLS CUI [4,3]
C0027627
Patient who has a good overall health status(world health organization (who) performance status 0-2).
Description

Overall health status

Data type

boolean

Alias
UMLS CUI [1,1]
C0018759
UMLS CUI [1,2]
C1298650
Patient who has appropriate renal conditions confirmed by test results for taking part in the study.
Description

Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2348568
Patient with measurable disease (at least one lesion, not irradiated within 12 weeks of study registration, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with ct or mri).
Description

Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C3846110
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C1301886
Patient with evidence of non-childbearing status or postmenopausal status.
Description

Pregnancy

Data type

text

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0232970
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
Patient with brain metastases or spinal cord compression.
Description

Brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0037926
Patient with significant abnormal ecg (qtcb correction unmeasurable or more than 480 ms) findings and /or significant cardiac conditions or events, uncontrolled hypertension and evidence of severe lung disease.
Description

Comorbidities

Data type

boolean

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C3828433
UMLS CUI [3,1]
C1882512
UMLS CUI [3,2]
C1518373
UMLS CUI [4]
C0018799
UMLS CUI [5]
C0741923
UMLS CUI [6]
C1868885
UMLS CUI [7,1]
C0024115
UMLS CUI [7,2]
C0205082
Patient with abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
Description

Electrolytes and organ function

Data type

boolean

Alias
UMLS CUI [1,1]
C0032821
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C0373675
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0201925
UMLS CUI [3,2]
C0205161
UMLS CUI [4]
C0151577
UMLS CUI [5,1]
C1254358
UMLS CUI [5,2]
C0205161
UMLS CUI [6]
C0151613
Patient with significant abnormal laboratory findings (to include abnormal liver function tests (bilirubin more than 1.5xulrr, and alt, ast, or alp more than 2.5xulrr or 5.0xulrr if related to liver metastases).
Description

Abnormal laboratory findings

Data type

boolean

Alias
UMLS CUI [1]
C0438215
UMLS CUI [2]
C3888966
UMLS CUI [3]
C0311468
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151849
Prior treatment received within 28 days before registration.
Description

Prior treatment = major surgery, radiation therapy, chemotherapy, or other investigational drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332185
Back to the top of the page

Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age and consent
Item
Written consent from female or male japanese patients aged 20 years and over.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C1556094 (UMLS CUI [3])
Diagnosis
Item
Patient with previous diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic medullary thyroid carcinoma(mtc).
boolean
C1833921 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0677984 (UMLS CUI [1,3])
C1710166 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0677984 (UMLS CUI [2,3])
C1833921 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C1710166 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
Overall health status
Item
Patient who has a good overall health status(world health organization (who) performance status 0-2).
boolean
C0018759 (UMLS CUI [1,1])
C1298650 (UMLS CUI [1,2])
Renal function
Item
Patient who has appropriate renal conditions confirmed by test results for taking part in the study.
boolean
C0232804 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Disease
Item
Patient with measurable disease (at least one lesion, not irradiated within 12 weeks of study registration, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with ct or mri).
boolean
C1513041 (UMLS CUI [1])
C3846110 (UMLS CUI [2])
C0221198 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
Pregnancy
Item
Patient with evidence of non-childbearing status or postmenopausal status.
text
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Brain metastases
Item
Patient with brain metastases or spinal cord compression.
boolean
C0220650 (UMLS CUI [1])
C0037926 (UMLS CUI [2])
Comorbidities
Item
Patient with significant abnormal ecg (qtcb correction unmeasurable or more than 480 ms) findings and /or significant cardiac conditions or events, uncontrolled hypertension and evidence of severe lung disease.
boolean
C0438154 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C3828433 (UMLS CUI [2])
C1882512 (UMLS CUI [3,1])
C1518373 (UMLS CUI [3,2])
C0018799 (UMLS CUI [4])
C0741923 (UMLS CUI [5])
C1868885 (UMLS CUI [6])
C0024115 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
Electrolytes and organ function
Item
Patient with abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
boolean
C0032821 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0373675 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0201925 (UMLS CUI [3,1])
C0205161 (UMLS CUI [3,2])
C0151577 (UMLS CUI [4])
C1254358 (UMLS CUI [5,1])
C0205161 (UMLS CUI [5,2])
C0151613 (UMLS CUI [6])
Abnormal laboratory findings
Item
Patient with significant abnormal laboratory findings (to include abnormal liver function tests (bilirubin more than 1.5xulrr, and alt, ast, or alp more than 2.5xulrr or 5.0xulrr if related to liver metastases).
boolean
C0438215 (UMLS CUI [1])
C3888966 (UMLS CUI [2])
C0311468 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151849 (UMLS CUI [5])
Prior treatment
Item
Prior treatment received within 28 days before registration.
boolean
C1514463 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
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