Clinical trial NCT00417677 (phase 1/phase 2, status: terminated)
Conditions: renal cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: combination of temsirolimus and sunitinib
SMILES: CCN(CC)CCNC(=O)C1=C(C)NC(\C=C2/C(=O)NC3=C2C=C(F)C=C3)=C1C
Reason stopped: 
    decision was made not to attempt a lower dose
  
Eligibility criteria:

        Inclusion Criteria for Dose Escalation Phase

          1. Histologically confirmed advanced RCC.

          2. Up to 2 prior systemic regimens for RCC.

          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).

               -  More criteria apply

        Exclusion Criteria for Dose Escalation Phase

          1. Subjects with known active central nervous system (CNS) malignancy (primary or
             metastatic).

          2. Prior therapy with sirolimus, temsirolimus or sunitinib.

          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.

               -  More criteria apply

        Inclusion Criteria for Expanded Cohort Phase

          1. Subjects with histologically confirmed advanced RCC regardless of nephrectomy status
             who have received no prior systemic therapies for their disease.

          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.

          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).

               -  More Criteria apply

        Exclusion Criteria for the Expanded Cohort Phase

          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).

          2. Prior anti-vascular endothelial growth factor (anti-VEGF) therapies (with either
             monoclonal antibodies and/or tyrosine kinase inhibitors [TKIs]) and/or mTOR
             inhibitors.

          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.

               -  More Criteria apply