A Phase 1 Dose Escalation Study of AMG 780 in Adult Subjects With Advanced Solid Tumors

Amgen

Status and phase

Terminated

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: AMG 780

Study type

Interventional

Funder types

Industry

Identifiers

NCT01137552

20070879

Details and patient eligibility

About

This is a first in human, open-label, sequential dose escalation and expansion study of AMG 780 in up to 62 subjects with advanced solid tumors. The dose escalation part of the study is aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AMG 780. The dose expansion will consist of up to 20 subjects and the dose level of AMG 780 will be dependent upon emerging safety and PK data from the dose escalation part of the study.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 form

Exclusion criteria

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