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A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of AMG 386 in Adult Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of AMG 386 in Adult Patients With Advanced Solid Tumors

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Outcome Measure:

Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.

Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Tumors
  • Solid Tumor
  • Metastatic Cancer
  • Advanced Solid Tumors