ID

36143

Beschreibung

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

Stichworte

Versionen (2)
  1. 17.04.19 17.04.19 -
  2. 17.04.19 17.04.19 -
Rechteinhaber

Genzyme Sanofi Company

Hochgeladen am

17. April 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma NCT01661179

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age and consent

Datentyp

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).
Beschreibung

Diagnosis

Datentyp

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).
Beschreibung

Overall health status

Datentyp

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.
Beschreibung

Renal function

Datentyp

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).
Beschreibung

Disease

Datentyp

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.
Beschreibung

Pregnancy

Datentyp

text

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

Exclusion Criteria

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

Brain metastases

Datentyp

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.
Beschreibung

Comorbidities

Datentyp

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.
Beschreibung

Electrolytes and organ function

Datentyp

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).
Beschreibung

Abnormal laboratory findings

Datentyp

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.
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332185
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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