| Exclusion Criteria: | 1) Prior cytotoxic chemotherapy within 3 years.
2) Previous anticancer therapy using biologics or vaccines within the last 6 months. Previous treatment with bevacizumab is not allowed.
3) Any treatment modalities, involving radiation and surgery, not discontinued at least 4 weeks prior to treatment in this study.
4) Myocardial infarction or any acute coronary syndrome within one year or current uncontrolled arrhythmias, symptomatic uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled hypertension.
5) History of pancreatitis.
6) Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
7) Concurrent use of other anti-cancer agents or treatments (a stable dose of LHRH agonists, bicalutamide, (e.g.Casodex) and/or other antiandrogens is allowed).
8) Known brain metastases.
9) Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
10) Concomitant systemic treatment with warfarin and/or corticosteroids corresponding to prednisolone dose above 5 mg/day.
11) Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 14 days prior to inclusion.
12) Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
13) Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic virus hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study). |