A Study of AMG 820 in Subjects With Advanced Solid Tumors - Full Text View

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:	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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 machophages (TAMS) as assessed by tumor biopsy at 9 weeks. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	September 2011
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	June 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

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

Contacts

Contact: Amgen Call Center

866-572-6436

Locations

United States, Pennsylvania
Research Site	Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Research Site	Recruiting
Greenville, South Carolina, United States, 29605
United States, Texas
Research Site	Recruiting
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

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:	July 12, 2012
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 May 23, 2013