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])