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A Study of AMG 820 in Subjects 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: NCT01444404
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):

Brief Summary:
First in human, open-label, sequential dose escalation and expansion study of AMG 820 in subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors Drug: AMG 820 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics of AMG 820 in Adult Subjects With Advanced Solid Tumors
Actual Study Start Date : March 31, 2008
Actual Primary Completion Date : February 6, 2014
Actual Study Completion Date : February 6, 2014

Arm Intervention/treatment
Experimental: Dose Expansion
The dose expansion will consist of up to 20 subjects and the dose level of AMG 820 will be dependent upon emerging safety and PK data from the dose escalation part of the study.
Drug: AMG 820
AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.

Experimental: Dose Escalation
The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 820.
Drug: AMG 820
AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.

Primary Outcome Measures :
  1. Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose [ Time Frame: 3 years ]
  2. Dose of AMG 820 where clinically significant or ≥ Grade 3 changes in safety laboratory tests, physical examinations, ECGs, or vitals signs in all subjects enrolled is greater than 33%. [ Time Frame: 3 years ]
  3. Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks. [ Time Frame: 3 years ]

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:

  • Men or women ≥ 18 years old
  • Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor
  • Measurable disease per RECIST 1.1 guidelines
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  • Part 2 - Dose Expansion only: Subjects must have tumor tissue that is accessible for core needle biopsy by using minimally invasive procedures and must consent to undergo biopsies of the tumor
  • Able to fast 4 to 6 hours for FDG-PET/CT scan, except subjects with prostate or bladder cancers
  • Competent to sign and date an Institutional Review Board approved informed consent form
  • Adequate hematologic, renal and hepatic function as determined by laboratory blood and urine tests

Exclusion Criteria:

  • Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 4 months after receiving the last dose of study drug.
  • Women who are lactating/breastfeeding or planning to become pregnant during the duration of the study
  • Primary central nervous system (CNS) tumors or CNS metastases
  • History of presence of hematological malignancies
  • History of arterial or venous thrombosis within 6 months of study enrollment
  • History of bleeding diathesis
  • Myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (New York Heart Association > class II), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension
  • Hypertension not adequately controlled with medication (diastolic > 90mmHG; systolic > 140 mmHG)
  • Left ventricular ejection fraction (LVEF) ≤ 50%
  • Active infection requiring (IV) antibiotics within 2 weeks of study enrollment
  • Known positive test for human immunodeficiency virus (HIV)
  • Known chronic hepatitis B or hepatitis C infection
  • Positive test for hepatitis B surface antigen or hepatitis C antibody
  • Known history of tuberculosis (TB), exposure to active TB-infected individuals, or positive TB skin test (tuberculin or purified protein derivative (PPD) test) upon study entry (subjects previously vaccinated for TB are not excluded unless there is evidence of active TB)
  • Anti-tumor therapy within 4 weeks of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent
  • Concurrent or prior anticoagulation therapy within 28 days of study day 1
  • Major surgery within 28 days of study day 1
  • Any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor

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): NCT01444404

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United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29605
United States, Texas
Research Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen Identifier: NCT01444404    
Other Study ID Numbers: 20060347
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Keywords provided by Amgen:
Solid Tumors
Phase 1
Clinical Trial
Additional relevant MeSH terms:
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