ID

35154

Beschreibung

A Study of Varlilumab (Anti-CD27) and Sunitinib in Patients With Metastatic Clear Cell Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT02386111

Link

https://clinicaltrials.gov/show/NCT02386111

Stichworte

Versionen (1)
  1. 20.02.19 20.02.19 -
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See clincaltrials.gov

Hochgeladen am

20. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Eligibility Carcinoma, Renal Cell NCT02386111

Englisch

Eligibility Carcinoma, Renal Cell NCT02386111

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
Beschreibung

Clear Cell Renal Cell Carcinoma predominant

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279702
UMLS CUI [1,2]
C1542147
2. advanced metastatic disease
Beschreibung

Neoplasm Metastasis Advanced

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205179
3. documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
Beschreibung

Progressive Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1335499
4. for phase l, no more than 3 prior anticancer regimens and for phase ll, no more than 1 prior anticancer regimen (il-2 or interferon do not count towards the total).
Beschreibung

Cancer treatment Quantity | Count Independent of Interleukin-2 | Count Independent of Interferon

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0750480
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0021756
UMLS CUI [3,1]
C0750480
UMLS CUI [3,2]
C0332291
UMLS CUI [3,3]
C3652465
5. measurable (target) disease.
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
6. life expectancy ≥ 12 weeks.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
7. if of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 70 days following last treatment dose.
Beschreibung

Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
8. must have available tumor tissue and consent to biopsy while on study.
Beschreibung

Availability of Tumor tissue sample | Consent Biopsy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C1511481
UMLS CUI [2,2]
C0005558
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior therapy with an anti-cd27 antibody.
Beschreibung

CD27 Antibody

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0054949
UMLS CUI [1,2]
C0003241
2. previous treatment with sunitinib.
Beschreibung

Prior Therapy Sunitinib

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1176020
3. use of any experimental immunotherapy.
Beschreibung

Immunotherapy Investigational

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021083
UMLS CUI [1,2]
C1517586
4. chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
Beschreibung

Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0392920
5. systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
Beschreibung

Systemic Radiation Therapy | Therapeutic radiology procedure Focal | Radiopharmaceuticals | Strontium | Samarium

Datentyp

boolean

Alias
UMLS CUI [1]
C2985381
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205234
UMLS CUI [3]
C0182638
UMLS CUI [4]
C0038467
UMLS CUI [5]
C0036147
6. use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
Beschreibung

Immunosuppressive Agents | CORTICOSTEROIDS FOR SYSTEMIC USE

Datentyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C3653708
7. other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
Beschreibung

Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in Situ Treated | Exception Disease Free Duration

Datentyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0007099
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
8. active, untreated central nervous system metastases.
Beschreibung

CNS metastases Untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0332155
9. active autoimmune disease or a documented history of autoimmune disease.
Beschreibung

Autoimmune Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004364
10. active diverticulitis.
Beschreibung

Diverticulitis

Datentyp

boolean

Alias
UMLS CUI [1]
C0012813
11. significant cardiovascular disease including chf or poorly controlled hypertension.
Beschreibung

Cardiovascular Disease | Congestive heart failure | Poor hypertension control

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0421190
12. impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.
Beschreibung

Impaired gastrointestinal system function | Gastrointestinal Disease Changing Absorption Sunitinib

Datentyp

boolean

Alias
UMLS CUI [1]
C0232459
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1176020
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Ähnliche Modelle

Eligibility Carcinoma, Renal Cell NCT02386111

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Clear Cell Renal Cell Carcinoma predominant
Item
1. histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
boolean
C0279702 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Neoplasm Metastasis Advanced
Item
2. advanced metastatic disease
boolean
C0027627 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Progressive Disease
Item
3. documented progressive disease based on radiographic, clinical or pathologic assessment during or subsequent to last therapy.
boolean
C1335499 (UMLS CUI [1])
Cancer treatment Quantity | Count Independent of Interleukin-2 | Count Independent of Interferon
Item
4. for phase l, no more than 3 prior anticancer regimens and for phase ll, no more than 1 prior anticancer regimen (il-2 or interferon do not count towards the total).
boolean
C0920425 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0750480 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0021756 (UMLS CUI [2,3])
C0750480 (UMLS CUI [3,1])
C0332291 (UMLS CUI [3,2])
C3652465 (UMLS CUI [3,3])
Measurable Disease
Item
5. measurable (target) disease.
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy ≥ 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
7. if of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 70 days following last treatment dose.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Availability of Tumor tissue sample | Consent Biopsy
Item
8. must have available tumor tissue and consent to biopsy while on study.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1511481 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
CD27 Antibody
Item
1. prior therapy with an anti-cd27 antibody.
boolean
C0054949 (UMLS CUI [1,1])
C0003241 (UMLS CUI [1,2])
Prior Therapy Sunitinib
Item
2. previous treatment with sunitinib.
boolean
C1514463 (UMLS CUI [1,1])
C1176020 (UMLS CUI [1,2])
Immunotherapy Investigational
Item
3. use of any experimental immunotherapy.
boolean
C0021083 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Chemotherapy
Item
4. chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to the planned start of study treatment.
boolean
C0392920 (UMLS CUI [1])
Systemic Radiation Therapy | Therapeutic radiology procedure Focal | Radiopharmaceuticals | Strontium | Samarium
Item
5. systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks, or radiopharmaceuticals (strontium, samarium) within 8 weeks prior to the first dose of study treatment.
boolean
C2985381 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0205234 (UMLS CUI [2,2])
C0182638 (UMLS CUI [3])
C0038467 (UMLS CUI [4])
C0036147 (UMLS CUI [5])
Immunosuppressive Agents | CORTICOSTEROIDS FOR SYSTEMIC USE
Item
6. use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to first dose of study treatment.
boolean
C0021081 (UMLS CUI [1])
C3653708 (UMLS CUI [2])
Cancer Other | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in Situ Treated | Exception Disease Free Duration
Item
7. other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007099 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
CNS metastases Untreated
Item
8. active, untreated central nervous system metastases.
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Autoimmune Disease
Item
9. active autoimmune disease or a documented history of autoimmune disease.
boolean
C0004364 (UMLS CUI [1])
Diverticulitis
Item
10. active diverticulitis.
boolean
C0012813 (UMLS CUI [1])
Cardiovascular Disease | Congestive heart failure | Poor hypertension control
Item
11. significant cardiovascular disease including chf or poorly controlled hypertension.
boolean
C0007222 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0421190 (UMLS CUI [3])
Impaired gastrointestinal system function | Gastrointestinal Disease Changing Absorption Sunitinib
Item
12. impairment of gastrointestinal function or gastrointestinal disease that may alter the absorption of sunitinib.
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1176020 (UMLS CUI [2,4])
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