Study Stopped
Part A, the dose escalation and primary objective of the study, was completed. Part B, the dose expansion, was not conducted due to a business decision.
A Phase 1 Dose Escalation Study of AMG 780 in Adult Subjects With Advanced Solid Tumors
A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 780 in Adult Subjects With Advanced Solid Tumors
1 other identifier
interventional
44
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2010
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMarch 4, 2015
February 1, 2015
3.5 years
April 22, 2010
March 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
2.5 years
To evaluate the pharmacokinetic (PK) parameters of AMG 780 including, but not limited to Cmax, AUC, and accumulation ratio
2.5 years
Secondary Outcomes (4)
To evaluate tumor response using RECIST criteria (measured by CT/MRI)
2.5 years
To evaluate changes in tumor volume (measured by volumetric CT/MRI)
2.5 years
To evaluate changes in tumor vascularity and to estimate the relationship between dose/pharmacokinetics and vascular response (measured by DCE-MRI)
2.5 years
To evaluate the incidence of anti-AMG 780 antibody formation
2.5 years
Study Arms (2)
A
EXPERIMENTALDose Escalation
B
EXPERIMENTALDose Expansion
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (3)
Research Site
Los Angeles, California, 90048, United States
Research Site
Durham, North Carolina, 27710, United States
Research Site
Cleveland, Ohio, 44106, United States
Related Publications (1)
Crockett SD, Barry EL, Mott LA, Snover DC, Wallace K, Baron JA. Predictors of Incident Serrated Polyps: Results from a Large Multicenter Clinical Trial. Cancer Epidemiol Biomarkers Prev. 2022 May 4;31(5):1058-1067. doi: 10.1158/1055-9965.EPI-21-1226.
PMID: 35506244DERIVED
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
June 4, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2013
Study Completion
April 1, 2014
Last Updated
March 4, 2015
Record last verified: 2015-02