An Open-Label, Randomized, Phase 1b Study Evaluating the Effect of Different Doses of AMG 706 on the Gallbladder in Subjects With 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