Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
