A Phase 1 Dose Escalation Study of AMG 780 in Adult 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Phase 1 Study of AMG 208 in Subjects With Advanced Solid Tumors

NCT00813384

Cancer Oncology Tumors +3 more

COMPLETED PHASE1

A Study of AMG 820 in Subjects With Advanced Solid Tumors

NCT01444404

Advanced Malignancy Advanced Solid Tumors Cancer +3 more

COMPLETED PHASE1

Safety Study of AMG 228 to Treat Solid Tumors

NCT02437916

Advanced Malignancy Advanced Solid Tumors Cancer +8 more

TERMINATED PHASE1

A Phase 1 First-in-Human Study Evaluating AMG 900 in Advanced Solid Tumors

NCT00858377

Advanced Malignancy Advanced Solid Tumors Cancer +2 more

COMPLETED PHASE1

Study of AMG 256 in Adult Subjects With Advanced Solid Tumors

NCT04362748

Advanced Solid Tumors

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Dose Escalation

Group Type EXPERIMENTAL

AMG 780

Intervention Type DRUG

AMG 780 will be administered by IV infusion every 2 weeks

B

Dose Expansion

Group Type EXPERIMENTAL

AMG 780

Intervention Type DRUG

AMG 780 will be administered by IV infusion every 2 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AMG 780

AMG 780 will be administered by IV infusion every 2 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No