A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function

Inclusion criteria

• Men or women ≥ 18 years of age
• Must have a pathologically documented, and definitively diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available, or for subjects who refuse standard therapy
• Evaluable OR measurable disease by RECIST 1.1 criteria
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
• Life expectancy of > 3 months, in the opinion of and as documented by the investigator
• Subject or subject's legally acceptable representative has provided informed consent

Exclusion criteria

• Subjects with gastric cancer or any malignancy with purely squamous cell histology
• Known history of primary central nervous system (CNS) tumors or CNS metastases
• Myocardial infarction within 1 year before study day 1, unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association > class II, uncontrolled hypertension [diastolic > 90 mmHg; systolic > 150 mmHg in repeated measurements])
• History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year before study day 1
• Active grade 2 or greater peripheral vascular disease or peripheral edema
• History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
• Non-healing wound, ulcer (including gastrointestinal) or fracture
• Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection
• Major surgery within 4 weeks before study day 1
• Absolute neutrophils count (ANC) < 1.0 x 10^9/L; or platelet count < 100 x 10^9/L; or hemoglobin < 9 g/dL; or PTT / aPTT > 1.5 x institutional upper limit of normal (ULN) ); or INR > 1.5
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN (> 5.0 x ULN if liver metastases present)
• Alkaline phosphatase > 2.5 x ULN (> 5.0 x ULN if attributable to liver or bone metastasis)
• Total bilirubin > 1.5 x ULN
• Other investigational procedures during the study
• Previous anti-cancer therapy or investigational agent within 4 weeks prior to study day 1
• Anticoagulation therapy within 4 weeks of study day 1 and while on study (except low dose warfarin (≤ 2 mg/kg) for prophylaxis against central venous catheter thrombosis)
• Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 6 months after the last dose of AMG 386. Highly effective methods of birth control include sexual abstinence (men, women); vasectomy or a condom with spermicide (men) in combination with barrier methods, hormonal birth control or IUD (women).
• Women who are lactating/breastfeeding.
• Women with a positive pregnancy test.