Tumors
Conditions
Keywords
Solid Tumor, Metastatic Cancer, Advanced Solid Tumors
Brief summary
The purpose of this study is to test the safety, tolerability and pharmacokinetic (PK) profile of AMG 386 after intravenous administration in adult subjects with advanced solid tumors.
Interventions
DRUGAMG 386
Sponsors
Amgen
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Have evaluable disease - Must be able to undergo MRI evaluation: 1. Must not have cardiac pacemakers or neurostimulators not specifically approved for use in the MRI environment; 2. Must not have metal implants, other than those approved as safe for use in MRI; 3. Must not be claustrophobic or have physical characteristics that will preclude undergoing MRI; - Subjects enrolling to the Dose Expansion Cohort must have at least one tumor that is amenable to DCE-MRI evaluation (e.g., greater than or equal to 3 cm lesion outside the thoracic cavity) - Have Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 - Adequate hematologic, renal and hepatic function
Exclusion criteria
- Presence of untreated CNS metastasis or symptoms of brain metastases - Presence of leukemia or myelodysplastic syndrome - History of high-dose chemotherapy requiring bone marrow or peripheral stem cell support - Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure \[NYHA greater than class II\], uncontrolled hypertension \[diastolic greater than 85 mmHg; systolic greater than 145 mmHg\] or cardiac arrhythmia) - History of arterial thrombosis (i.e., stroke, transient ischemic attack or myocardial infarction) within 6 months of study day 1 - History of bleeding diathesis or hypercoagulopathy within 6 months of study day 1 - Active peptic ulcer disease or gastritis - Unresolved toxicities from prior anti-cancer therapy, excluding alopecia - Anti-tumor treatment within 3 weeks of study day 1. If anti-tumor treatment was an antibody therapy, the interval must be 6 weeks - Anticoagulation therapy, except a low dose of Coumadin™ (less than 2 mg) for prophylaxis against central catheter-related thrombosis - Major surgery within 4 weeks of study day 1 - History of allergic reaction to bacterially produced proteins - Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus or chronic hepatitis B infection - Pregnant or breastfeeding - Not using adequate contraceptive precautions, in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study. | — |
| Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in DCE-MRI imaging results measured at baseline, Week 1, and Week 4. | — |
| Changes in blood levels of angiogenic cytokines measured at baseline, Day 3, Weeks 2, 4, 10, and every 8 weeks thereafter. | — |
| Anti-AMG 386 antibody formation measured at baseline, weeks 2, 4, 6, and every 4 weeks thereafter. | — |
| Tumor response measure by CT scan at baseline, Week 4, and every 8 weeks thereafter. | — |
Outcome results
None listed