A Study of AMG 820 in Subjects With Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01444404
First received: September 1, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Advanced Malignancy
Advanced Solid Tumors
Cancer
Oncology
Oncology Patients
Tumors
Drug: AMG 820
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change in tumor associated macrophages (TAMS) as assessed by tumor biopsy at 9 weeks. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444404

Locations
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
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01444404     History of Changes
Other Study ID Numbers: 20060347
Study First Received: September 1, 2011
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Solid Tumors
Phase 1
Clinical Trial

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014