Clinical Trial: Trebananib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: Gynecologic Oncology Group

Current Primary Outcome:

  • Adverse events as assessed by NCI CTCAE v 4.0 [ Time Frame: Up to 5 years ]
  • Objective tumor response (complete or partial response) [ Time Frame: Up to 5 years ]
  • Progression-free survival [ Time Frame: At 6 months ]


Original Primary Outcome:

  • Progression-free survival for at least 6 months
  • Objective tumor response (complete or partial response)
  • Adverse events as assessed by NCI CTCAE v 4.0


Current Secondary Outcome:

  • Overall survival [ Time Frame: From the date of study entry, and death due to any cause will be considered a failure event, assessed up to 5 years ]
    Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.
  • Progression-free survival [ Time Frame: From the date of study entry, and death due to any cause will be considered a failure event, assessed up to 5 years ]
    Will be characterized with Kaplan-Meier plots and estimates of the median time until death or progression.


Original Secondary Outcome:

  • Progression-free survival
  • Overall survival


Information By: Gynecologic Oncology Group

Dates:
Date Received: September 25, 2010
Date Started: June 2011
Date Completion:
Last Updated: May 3, 2017
Last Verified: May 2017