An Open-label Pharmacokinetic Study of AMG 386 in Advanced 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.