| Exclusion Criteria: | 1) Discontinued from an AMG 706 study due to an adverse event considered by the investigator to be related to AMG 706 treatment, including intolerance to AMG 706, or for any other reason that a subject's safety could be compromised with continued AMG 706 treatment
2) Has been off AMG 706 treatment for > 42 days before study day 1
3) Participating in any intervening investigational device or drug study(s) between the previous AMG 706 study and this AMG 706 study, or is receiving any investigational agent(s) other than AMG 706
4) Uncontrolled hypertension (resting blood pressure >140/90 mm Hg). Anti-hypertensieve medications are allowed if the subject is stable on their current dose at time of study day 1
5) Requires additional systemic anticancer therapy for the primary tumor
6) The following laboratory exclusion criteria are applicable for subjects whose last date of AMG 706 treatment on a previous study has been ≥ 14 days: Absolute neutrophil count (ANC) < 1.0 x 109 /L Platelet count < 100 x 109 /L Hemoglobin < 9 g/dL Serum creatinine > 2.0 mg/dL (> 177 μmol/L) or calculated clearance < 40 mL/min Aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) (if liver metastases are present ≥ 5 x ULN)Alanine aminotransferase (ALT) > 2.5 x ULN (if liver metastases are present ≥ 5 x ULN)
7) Alanine aminotransferase (ALT) > 2.5 x ULN (if liver metastases are present ≥ 5 x ULN) Alkaline phosphatase > 2.0 x ULN (if liver or bone metastases are present ≥ 5 x ULN) Total bilirubin ≥ 2.0 x ULN (except for subjects with UGT1A1 promoter polymorphism, ie, Gilbert syndrome, confirmed by genotyping or InvaderŪ UGT1A1 Molecular Assay prior to randomization. Subjects enrolled with Gilbert syndrome must have a total bilirubin < 3 x ULN)
8) Subject of child-bearing potential is evidently pregnant (eg, positive beta-human chorionic gonadotropin test ) or is breastfeeding OR Is not using adequate contraceptive precautions
9) Has known sensitivity to any of the products to be administered during dosing Known hypersensitivity to study medication (AMG 706)
10) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
11) Subject has any medical condition that, in the investigator's opinion, makes the subject unsuitable for study participation
12) Not recovered from all previous non-AMG 706 therapies (eg, radiation, surgery)
13) History of uncontrolled central nervous system metastases
14) Major surgical procedure within 28 days prior to study day 1(unless prior approval granted by sponsor's medical monitor)
15) Minor surgical procedures within 14 days prior to study day 1(unless prior approval granted by sponsor's medical monitor)
16) Clinically significant cardiac disease within 12 months of study day 1, including myocardial infarction, unstable angina, Grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or ongoing arrhythmias requiring medication
17) Any condition which in the investigator's opinion makes the subject unsuitable for study participation
18) Unable to take oral medications
19) Previously enrolled and treated with AMG 706 on this extension study
20) Unable to comply with study requirements |