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A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 780 in Adult Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Advanced Solid Tumors

Thank you

Trial Information

A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 780 in Adult Subjects With Advanced Solid Tumors

Inclusion Criteria:

- Men and women ≥ 18 years old

- Must have a pathologically documented, and definitely diagnosed, advanced solid tumor
that is refractory to standard treatment, or for which no curative therapy is
available, or for subjects who refuse standard therapy

- Measurable disease by RECIST criteria

- Must be able to undergo MRI evaluation

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

- Competent to sign and date an Institutional Review Board approved informed consent

Exclusion Criteria:

- Presence of untreated or symptomatic primary central nervous system tumors or

- Presence of leukemia or myelodysplastic syndrome

- Subjects with head and neck cancer

- Previous hematopoietic stem cell transplant (allogeneic)

- Unresolved hematological toxicities > grade 1 with the exception of grade 2
lymphopenia and non-hematological toxicities > grade 1, excluding alopecia and grade
2 neuropathy, from prior anti-cancer therapy

- Myocardial infarction within 1 year before study day 1, or unstable or uncontrolled
disease/condition related to or affecting cardiac function

- History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year
before study

- Active peripheral vascular disease

- History of bleeding diathesis

- History of pulmonary hemorrhage or gross hemoptysis within 6 months before study

- Known history of adrenal hemorrhage

- Known positive test for human immunodeficiency virus infection, or active hepatitis B
or hepatitis C

- Major surgery within 1 month before study

- Prior treatment with any agent targeting the angiopoietin-Tie2 signaling pathway

- Concurrent antitumor treatment, except Lupron for subjects with prostate cancer and
selective estrogen receptor modulators (SERMS) for subjects with breast cancer,
within 4 weeks (6 weeks for nitrosoureas or mitomycin) before study day 1

- Known sensitivity to mammalian-derived products, bacterially-produced proteins, or
any of the products to be administered during dosing

- Investigational agent within 30 days before study

- Pregnant (eg, positive urine test) or breastfeeding

- Subjects of childbearing potential, or subject who has a partner of childbearing
potential, and is not using highly effective contraceptive precautions

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the safety and tolerability of AMG 780 in subjects with advanced solid malignancies (including adverse event rate, incidence of dose-limiting toxicities, and determination of maximum tolerated dose)

Outcome Time Frame:

2.5 years

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

April 2013

Related Keywords:

  • Advanced Solid Tumors
  • First-In-Human
  • Dose Escalation
  • Dose Expansion
  • Advance Solid Tumors
  • Anti-Angiopoietin
  • Advance Malignancy
  • Cancer
  • Oncology
  • Oncology Patients
  • Phase 1
  • Clinical Trial
  • Tumors
  • Solid Tumors
  • Angiogenesis Inhibitors
  • Neoplasms



Research Site Anaheim, California  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio