Clinical trial NCT00384969 (phase 1, status: completed)
Conditions: renal cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: rad001 and sorafenib
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically- or cytologically-confirmed renal cell carcinoma containing predominant
             (>50%) clear cell histology, which is metastatic or unresectable

          2. Cytoreductive nephrectomy is allowed

          3. Evidence of RECIST-defined measurable disease (lesions that can be accurately measured
             in at least one dimension with the longest diameter ≥ 20mm using conventional
             techniques or ≥10 mm with spiral CT scan)

          4. Male or female at least 21 years old

          5. ECOG performance status 0-1

          6. Adequate bone marrow function:

               1. ANC ≥ 1500/uL

               2. platelet count ≥ 100,000/uL

               3. hemoglobin ≥ 9.0 g/dL

          7. Adequate hepatic function:

               1. Total bilirubin ≤ 1.5 X ULN

               2. AST (SGOT) ≤ 2.5 X ULN

               3. ALT (SGPT) ≤ 2.5 X ULN

          8. Adequate renal function as determined by either:

               1. Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated
                  creatinine clearance, Cockroft-Gault equation will be used) Modified
                  Cockcroft-Gault formula: ((140 - age(yrs)) x (actual weight(kg))) / (72 x serum
                  creatinine(mg/dl))

                  * Multiply by another factor of 0.85 if female

               2. Serum creatinine ≤ 1.5 X ULN

          9. Able to swallow oral medications

         10. Resolution of any pre-existing toxicity from prior therapy to NCI CTCAE V3.0 ≤ grade 1

         11. Signed and dated informed consent document

         12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
             tests, and other study procedures

         13. More than 28 days since any prior therapy, including investigational agents and
             surgical procedures

        Exclusion Criteria:

          1. Collecting duct, papillary, or chromophobe type renal cell carcinoma without a clear
             cell component are excluded. Transitional cell carcinoma of the renal pelvis is
             excluded

          2. No more than two prior systemic regimens for renal cell carcinoma

          3. Phase I: No prior treatment with sorafenib. Phase II: No prior treatment with prior
             anti-VEGF therapies, including sorafenib, sunitinib, thalidomide, or bevacizumab

          4. No prior treatment with RAD001, CCI-779, or similar agents

          5. Prior surgery, radiation therapy, or systemic therapy for renal cell carcinoma within
             4 weeks of starting study treatment

          6. History of or known brain metastasis, spinal cord compression, or carcinomatous
             meningitis, or new evidence of brain or leptomeningeal disease on screening CT or MRI
             scan

          7. Any of the following within 12 months prior to study drug administration: myocardial
             infarction, unstable or severe angina, coronary or peripheral artery bypass graft,
             NYHA functional Class II, III, IV congestive heart failure, cerebrovascular accident
             or transient ischemic attack, or pulmonary embolism

          8. Hypertension that is unable to be controlled with medications

          9. Known human immunodeficiency virus (HIV) or acquired immune deficiency syndrome
             (AIDS)-related illness

         10. "Currently active" second malignancy other than non-melanoma skin cancers. Patients
             are not considered to have a "currently active" malignancy if they have completed
             therapy and are considered to have a less than 30% risk of relapse

         11. Current treatment on another clinical trial

         12. Pregnant or breastfeeding

         13. Chronic treatment with systemic steroids or other immunosuppressive agent

         14. Patients with an active bleeding diathesis or on oral vitamin K antagonist medication
             (except low dose warfarin)

         15. History of malabsorption syndrome, disease significantly affecting gastrointestinal
             function or major resection of stomach or small bowel that could interfere with
             absorption, distribution, metabolism, or excretion of study drugs

         16. Any serious and/or unstable pre-existing medical, psychiatric, or other condition
             (including lab abnormalities) that could interfere with subject safety or obtaining
             informed consent. Examples of such include uncontrolled diabetes, nonhealing wound,
             severe infection, severe malnutrition, ventricular arrhythmias, active ischemic heart
             disease, chronic liver or renal disease, or active upper GI tract ulceration -