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A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics of AMG 820 in Adult Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Malignancy, Advanced Solid Tumors, Cancer, Oncology, Oncology Patients, Tumors

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Trial Information

A Phase 1, First-In-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacokinetics of AMG 820 in Adult Subjects With Advanced Solid Tumors


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Area Under Curve (AUC) Time Frame: predose, 0.5, 1, 2, 4, 8, 24 hours post-dose

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20060347

NCT ID:

NCT01444404

Start Date:

September 2011

Completion Date:

October 2014

Related Keywords:

  • Advanced Malignancy
  • Advanced Solid Tumors
  • Cancer
  • Oncology
  • Oncology Patients
  • Tumors
  • Solid Tumors
  • Phase 1
  • Clinical Trial
  • Neoplasms

Name

Location

Research SiteAllentown, Pennsylvania  
Research SiteCharleston, South Carolina  
Research SiteAbilene, Texas