Effect of Different Doses of AMG 706 on the Gallbladder in Advanced Solid Tumors

Inclusion criteria

• Histologically confirmed advanced metastatic solid tumor
• Ineligible to receive or progressed on standard of care therapies
• Measurable or non-measurable disease per modified RECIST
• Gallbladder must be in situ on screening ultrasound
• ECOG Performance Status of 0 to 2
• Life expectancy of 6 months or more as determined by the investigator
• Adequate organ and hematologic function as evidenced by laboratory studies prior to randomization
• Men and women 18 years or older

Exclusion criteria

• Uncontrolled CNS metastases
• Known history of prior cholecystitis, prior biliary procedure or prior or ongoing biliary disease
• Radiation therapy within 14 days prior to randomization
• Peripheral neuropathy > Grade 1 per CTC AE v.3
• Currently or previously treated with AMG 706 or other VEGF inhibitors such as SU11248 (sunitinib), PTK787 (vatalanib), AZD2171, BAY 43-9006 (sorafenib), ZD6474 (vandetanib)
• Previous treatment with bevacizumab is allowed if at least 6 weeks have elapsed from the last dose of bevacizumab to the date of randomization
• Any anti-coagulant therapy within 7 days prior to randomization; low dose heparin and warfarin for prophylaxis against central venous catheter thrombosis is allowed
• Less than 30 days have elapsed since participation in an investigational drug/device study or currently receiving investigational treatments
• History of arterial or venous thrombosis within 1 year prior to randomization
• History of bleeding diathesis or bleeding within 14 days of randomization
• MI, CVA, TIA, PTCA/stent, CHF, Grade 2 or greater PVD, uncontrolled arrhythmias or unstable angina within one year prior to randomization
• Uncontrolled HTN defined by a resting BP of >150/90 mmHg
• Surgery: major surgical procedure within 4 weeks or 28 days prior to randomization; minor surgical procedure, placement of access device or fine needle aspiration within 7 days of randomization; planned elective surgery while on study
• Non-healing or open wound, ulcer or fracture
• Known ongoing or active infection
• Known (+) for HIV, Hep C or Hep B surface antigen
• Known chronic hepatitis
• Known history of allergy or hypersensitivity to AMG 706 or any of its components
• Pregnant, ie, (+) b-HCG; breastfeeding