ID

31800

Description

A Study Combining Treatment With Temsirolimus and Sunitinib for Subjects With Advanced Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00417677

Link

https://clinicaltrials.gov/show/NCT00417677

Keywords

Versions (1)
  1. 9/28/18 9/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT00417677

English

Eligibility Renal Cell Carcinoma NCT00417677

1 forms  
Criteria
Description

Criteria

1. histologically confirmed advanced rcc.
Description

Renal Cell Carcinoma Advanced

Data type

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0205179
2. up to 2 prior systemic regimens for rcc.
Description

Systemic therapy Quantity Renal Cell Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0007134
3. subject must have at least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter ³10 mm when measured by spiral computed ct (5-mm slice thickness contiguous) or ³20 mm when measured by conventional ct (10-mm slice thickness contiguous) (lesion must be ³ 2 times the size of the slice thickness per recist).
Description

Measurable lesion Quantity | Measurable lesion Dimension Quantity | Longest Diameter Spiral CT | Slice Thickness | Longest Diameter CT

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0552406
UMLS CUI [3,2]
C0860888
UMLS CUI [4]
C3829566
UMLS CUI [5,1]
C0552406
UMLS CUI [5,2]
C0040405
more criteria apply
Description

Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
exclusion criteria for dose escalation phase
Description

Exclusion Criteria Dose Escalation

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C3816728
1. subjects with known active central nervous system (cns) malignancy (primary or metastatic).
Description

Malignant Central Nervous System Neoplasm Primary | Malignant Central Nervous System Neoplasm metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0348374
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0348374
UMLS CUI [2,2]
C1522484
2. prior therapy with sirolimus, temsirolimus or sunitinib.
Description

Sirolimus | temsirolimus | sunitinib

Data type

boolean

Alias
UMLS CUI [1]
C0072980
UMLS CUI [2]
C1707080
UMLS CUI [3]
C1176020
3. subjects receiving known strong cytochrome p450 (cyp)3a4 isoenzyme inhibitors and/or inducers. subjects receiving other cyp3a4 isoenzyme inhibitors and/or inducers not classified as strong inhibitors or inducers are eligible, provided they have been on a stable regimen for at least 4 weeks before screening.
Description

CYP3A4 Inhibitor Strong | CYP3A4 Inducer Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3830625
UMLS CUI [2,2]
C0442821
more criteria apply
Description

Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
inclusion criteria for expanded cohort phase
Description

Inclusion criteria Cohort Phase Expanded

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0599755
UMLS CUI [1,3]
C0205390
UMLS CUI [1,4]
C0205229
1. subjects with histologically confirmed advanced rcc regardless of nephrectomy status who have received no prior systemic therapies for their disease.
Description

Renal Cell Carcinoma Advanced | Independent of Nephrectomy status | Systemic therapy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C1404808
UMLS CUI [3,1]
C1515119
UMLS CUI [3,2]
C0332197
2. subjects with histologically confirmed advanced rcc regardless of nephrectomy status who have a least 4 weeks since prior treatment with palliative radiation therapy, and/or surgery and resolution of all toxic effects of prior therapy to nci ctcae (version 3.0) grade £1.
Description

Renal Cell Carcinoma Advanced | Independent of Nephrectomy status | Palliative Radiation Therapy | Palliative Surgery | Toxic effects Due to Prior Therapy | Resolution CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0007134
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C1404808
UMLS CUI [3]
C3898008
UMLS CUI [4]
C0282282
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C1514463
UMLS CUI [6,1]
C1514893
UMLS CUI [6,2]
C1516728
3. subjects must have at least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter ³10 mm when measured by spiral ct (5-mm slice thickness contiguous) or ³20 mm when measured by conventional ct (10-mm slice thickness contiguous) (lesion must be ³2 times the size of the slice thickness per recist).
Description

Measurable lesion Quantity | Measurable lesion Dimension Quantity | Longest Diameter Spiral CT | Slice Thickness | Longest Diameter CT

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C0439534
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0552406
UMLS CUI [3,2]
C0860888
UMLS CUI [4]
C3829566
UMLS CUI [5,1]
C0552406
UMLS CUI [5,2]
C0040405
more criteria apply
Description

Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
exclusion criteria for the expanded cohort phase
Description

Exclusion Criteria Cohort Phase Expanded

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0599755
UMLS CUI [1,3]
C0205390
UMLS CUI [1,4]
C0205229
1. subjects with a history of a cns malignancy or metastatic disease to the cns and subjects with a known, active cns malignancy (primary or metastatic).
Description

Medical History Malignant Central Nervous System Neoplasm | Medical History Neoplasm Metastasis Central Nervous System | Malignant Central Nervous System Neoplasm Primary | Malignant Central Nervous System Neoplasm metastatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0348374
UMLS CUI [2,1]
C0262926
UMLS CUI [2,2]
C0027627
UMLS CUI [2,3]
C3714787
UMLS CUI [3,1]
C0348374
UMLS CUI [3,2]
C0205225
UMLS CUI [4,1]
C0348374
UMLS CUI [4,2]
C1522484
2. prior anti-vascular endothelial growth factor (anti-vegf) therapies (with either monoclonal antibodies and/or tyrosine kinase inhibitors [tkis]) and/or mtor inhibitors.
Description

Vascular Endothelial Growth Factor Inhibitor | Monoclonal Antibodies | Tyrosine kinase inhibitor | mTOR Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C4521299
UMLS CUI [2]
C0003250
UMLS CUI [3]
C1268567
UMLS CUI [4]
C2746052
3. subjects receiving known strong cyp3a4 isoenzyme inhibitors and/or inducers. subjects taking other cyp3a4 isoenzyme inhibitors and/or inducers not classified as strong inhibitors or inducers are eligible, provided they have been on a stable regimen for at least 4 weeks before screening.
Description

CYP3A4 Inhibitor Strong | CYP3A4 Inducer Strong

Data type

boolean

Alias
UMLS CUI [1,1]
C3830624
UMLS CUI [1,2]
C0442821
UMLS CUI [2,1]
C3830625
UMLS CUI [2,2]
C0442821
more criteria apply
Description

Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Renal Cell Carcinoma NCT00417677

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Renal Cell Carcinoma Advanced
Item
1. histologically confirmed advanced rcc.
boolean
C0007134 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
Systemic therapy Quantity Renal Cell Carcinoma
Item
2. up to 2 prior systemic regimens for rcc.
boolean
C1515119 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0007134 (UMLS CUI [1,3])
Measurable lesion Quantity | Measurable lesion Dimension Quantity | Longest Diameter Spiral CT | Slice Thickness | Longest Diameter CT
Item
3. subject must have at least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter ³10 mm when measured by spiral computed ct (5-mm slice thickness contiguous) or ³20 mm when measured by conventional ct (10-mm slice thickness contiguous) (lesion must be ³ 2 times the size of the slice thickness per recist).
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0552406 (UMLS CUI [3,1])
C0860888 (UMLS CUI [3,2])
C3829566 (UMLS CUI [4])
C0552406 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
Criteria Additional
Item
more criteria apply
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Exclusion Criteria Dose Escalation
Item
exclusion criteria for dose escalation phase
boolean
C0680251 (UMLS CUI [1,1])
C3816728 (UMLS CUI [1,2])
Malignant Central Nervous System Neoplasm Primary | Malignant Central Nervous System Neoplasm metastatic
Item
1. subjects with known active central nervous system (cns) malignancy (primary or metastatic).
boolean
C0348374 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0348374 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Sirolimus | temsirolimus | sunitinib
Item
2. prior therapy with sirolimus, temsirolimus or sunitinib.
boolean
C0072980 (UMLS CUI [1])
C1707080 (UMLS CUI [2])
C1176020 (UMLS CUI [3])
CYP3A4 Inhibitor Strong | CYP3A4 Inducer Strong
Item
3. subjects receiving known strong cytochrome p450 (cyp)3a4 isoenzyme inhibitors and/or inducers. subjects receiving other cyp3a4 isoenzyme inhibitors and/or inducers not classified as strong inhibitors or inducers are eligible, provided they have been on a stable regimen for at least 4 weeks before screening.
boolean
C3830624 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3830625 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
Criteria Additional
Item
more criteria apply
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Inclusion criteria Cohort Phase Expanded
Item
inclusion criteria for expanded cohort phase
boolean
C1512693 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C0205390 (UMLS CUI [1,3])
C0205229 (UMLS CUI [1,4])
Renal Cell Carcinoma Advanced | Independent of Nephrectomy status | Systemic therapy Absent
Item
1. subjects with histologically confirmed advanced rcc regardless of nephrectomy status who have received no prior systemic therapies for their disease.
boolean
C0007134 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0332291 (UMLS CUI [2,1])
C1404808 (UMLS CUI [2,2])
C1515119 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Renal Cell Carcinoma Advanced | Independent of Nephrectomy status | Palliative Radiation Therapy | Palliative Surgery | Toxic effects Due to Prior Therapy | Resolution CTCAE Grades
Item
2. subjects with histologically confirmed advanced rcc regardless of nephrectomy status who have a least 4 weeks since prior treatment with palliative radiation therapy, and/or surgery and resolution of all toxic effects of prior therapy to nci ctcae (version 3.0) grade £1.
boolean
C0007134 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0332291 (UMLS CUI [2,1])
C1404808 (UMLS CUI [2,2])
C3898008 (UMLS CUI [3])
C0282282 (UMLS CUI [4])
C0600688 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C1514463 (UMLS CUI [5,3])
C1514893 (UMLS CUI [6,1])
C1516728 (UMLS CUI [6,2])
Measurable lesion Quantity | Measurable lesion Dimension Quantity | Longest Diameter Spiral CT | Slice Thickness | Longest Diameter CT
Item
3. subjects must have at least 1 measurable lesion that can be accurately measured in at least 1 dimension with the longest diameter ³10 mm when measured by spiral ct (5-mm slice thickness contiguous) or ³20 mm when measured by conventional ct (10-mm slice thickness contiguous) (lesion must be ³2 times the size of the slice thickness per recist).
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1513041 (UMLS CUI [2,1])
C0439534 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0552406 (UMLS CUI [3,1])
C0860888 (UMLS CUI [3,2])
C3829566 (UMLS CUI [4])
C0552406 (UMLS CUI [5,1])
C0040405 (UMLS CUI [5,2])
Criteria Additional
Item
more criteria apply
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Exclusion Criteria Cohort Phase Expanded
Item
exclusion criteria for the expanded cohort phase
boolean
C0680251 (UMLS CUI [1,1])
C0599755 (UMLS CUI [1,2])
C0205390 (UMLS CUI [1,3])
C0205229 (UMLS CUI [1,4])
Medical History Malignant Central Nervous System Neoplasm | Medical History Neoplasm Metastasis Central Nervous System | Malignant Central Nervous System Neoplasm Primary | Malignant Central Nervous System Neoplasm metastatic
Item
1. subjects with a history of a cns malignancy or metastatic disease to the cns and subjects with a known, active cns malignancy (primary or metastatic).
boolean
C0262926 (UMLS CUI [1,1])
C0348374 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C3714787 (UMLS CUI [2,3])
C0348374 (UMLS CUI [3,1])
C0205225 (UMLS CUI [3,2])
C0348374 (UMLS CUI [4,1])
C1522484 (UMLS CUI [4,2])
Vascular Endothelial Growth Factor Inhibitor | Monoclonal Antibodies | Tyrosine kinase inhibitor | mTOR Inhibitor
Item
2. prior anti-vascular endothelial growth factor (anti-vegf) therapies (with either monoclonal antibodies and/or tyrosine kinase inhibitors [tkis]) and/or mtor inhibitors.
boolean
C4521299 (UMLS CUI [1])
C0003250 (UMLS CUI [2])
C1268567 (UMLS CUI [3])
C2746052 (UMLS CUI [4])
CYP3A4 Inhibitor Strong | CYP3A4 Inducer Strong
Item
3. subjects receiving known strong cyp3a4 isoenzyme inhibitors and/or inducers. subjects taking other cyp3a4 isoenzyme inhibitors and/or inducers not classified as strong inhibitors or inducers are eligible, provided they have been on a stable regimen for at least 4 weeks before screening.
boolean
C3830624 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3830625 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
Criteria Additional
Item
more criteria apply
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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