A Study of AMG 820 in Subjects With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2014-02-06

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Malignancy Advanced Solid Tumors Cancer Oncology Oncology Patients Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

AMG 820

Intervention Type DRUG

AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.

Dose Escalation

The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 820.

Group Type EXPERIMENTAL

AMG 820

Intervention Type DRUG

AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No