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Study Evaluating AMG 386 in Adult Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00102830
Recruitment Status : Completed
First Posted : February 4, 2005
Last Update Posted : August 20, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Tumors Drug: AMG 386 Phase 1

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of AMG 386 in Adult Patients With Advanced Solid Tumors

Primary Outcome Measures :
  1. Adverse events, clinically significant changes in laboratory results, ECG, and vital signs, to be measured throughout the study.
  2. Pharmacokinetic Profile of AMG 386 - blood levels of AMG 386 to be measured throughout the study.

Secondary Outcome Measures :
  1. Changes in DCE-MRI imaging results measured at baseline, Week 1, and Week 4.
  2. Changes in blood levels of angiogenic cytokines measured at baseline, Day 3, Weeks 2, 4, 10, and every 8 weeks thereafter.
  3. Anti-AMG 386 antibody formation measured at baseline, weeks 2, 4, 6, and every 4 weeks thereafter.
  4. Tumor response measure by CT scan at baseline, Week 4, and every 8 weeks thereafter.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00102830

Sponsors and Collaborators
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Study Director: MD Amgen

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00102830    
Other Study ID Numbers: 20040169
First Posted: February 4, 2005    Key Record Dates
Last Update Posted: August 20, 2010
Last Verified: August 2010
Keywords provided by Amgen:
Solid Tumor
Metastatic Cancer
Advanced Solid Tumors
Additional relevant MeSH terms:
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Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents