Clinical trial NCT01313559 (phase 2, status: terminated)
Conditions: castrate resistant prostate cancer, chemotherapy naive prostate cancer, prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: pasireotide, everolimus
SMILES: NCCCC[C@@H]1NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@@H](NC(=O)[C@@H]2C[C@H](CN2C(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CC2=CC=C(OCC3=CC=CC=C3)C=C2)NC1=O)OC(=O)NCCN)C1=CC=CC=C1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion Criteria:

          -  Age minimum: 18 years old

          -  Histological confirmation of prostatic adenocarcinoma

          -  PSA > or = to 2 ng/ml

          -  PSA progression (serially rises on two occasions each at least one week apart) OR
             disease progression on imaging studies (CT scan or bone scan).

          -  Minimally symptomatic - no symptoms attributed to prostate cancer greater than Grade I
             based on NCI CTCAE Version 4.0 grading of toxicities

          -  Discontinuation of all antiandrogen, ketoconazole and investigational drugs for at
             least 4 weeks (6 weeks for bicalutamide) prior to study initiation

          -  Maintain castrate levels of testosterone (<50ng/dL)

          -  Karnofsky Performance Status > or = to 60%

          -  Life expectancy > 3 months

          -  Adequate hematologic, renal, and liver function

        Exclusion Criteria:

          -  Currently active second malignancy other than non-melanoma skin cancers.

          -  Clinically significant cardiovascular disease: EF < 30%, NHYA Class III or greater
             congestive heart failure, myocardial infarction/unstable angina within 6 months prior
             to study enrollment, or significant ECG abnormalities such as QRS/QT prolongation (see
             Section 5.3).

          -  Progressive pulmonary disease, such as advanced COPD, pulmonary fibrosis, or
             supplemental O2 requirement.

          -  Known CNS disease, except for treated brain metastases.

          -  Poorly controlled diabetes mellitus (HbA1c > 7 %) or fasting blood glucose level >126
             mg/dL in non-diabetic patients or > 189 mg/dL in diabetic patients (can be enrolled
             after initiation or titration of anti-diabetic agent(s)).

          -  Poorly controlled hypercholesterolemia (fasting serum cholesterol >300 mg/dL) or
             hypertriglyceridemia (> 2.5 x ULN). Patients above either threshold can be included
             after initiation of appropriate lipid lowering medication.

          -  Current use of chronic steroids (equivalent of 20mg prednisone daily). Inhaled
             steroids are acceptable.

          -  Active gallbladder disease or hepatitis (AST or ALT > 2.0, or bilirubin > 1.5x ULN),
             liver cirrhosis, or severe liver impairment (Child-Pugh class C). It is highly
             recommended that patients positive for HBV-DNA or HBsAg are treated prophylactically
             with an antiviral for 1-2 weeks prior to receiving study drug.

          -  Serum creatinine >1.5 upper limit of normal or on dialysis.

          -  Prior use of a somatostatin analog or mTOR inhibitor for the treatment of PC.