Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Tumors

• Registration Number: NCT00102830
• Lead Sponsor: Amgen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-02-03
• Study First Submitted QC: 2005-02-03
• Study First Posted: 2005-02-04
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-19
• Last Update Posted: 2010-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.