Clinical Trials Directory

Trials / Completed

CompletedNCT01210222

Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

A Phase II Trial of AMG 386, a Selective Angiopoietin 1/2 Neutralizing Peptibody, in Patients With Persistent/Recurrent Carcinoma of the Endometrium

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Gynecologic Oncology Group · Network
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies the side effects and how well trebananib works in treating patients with persistent or recurrent endometrial cancer. Trebananib may stop the growth of endometrial cancer by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with AMG 386 (trebananib). II. To determine the nature and degree of toxicity of AMG 386 in this cohort of patients. SECONDARY OBJECTIVES: I. To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with AMG 386. OUTLINE: Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALTrebananibGiven IV

Timeline

Start date
2011-06-06
Primary completion
2016-07-16
Completion
2016-07-16
First posted
2010-09-28
Last updated
2018-02-23
Results posted
2017-11-29

Locations

33 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01210222. Inclusion in this directory is not an endorsement.