AMG 386 in Treating Patients With Persistent or Recurrent Endometrial Cancer
RATIONALE: AMG 386 may stop the growth of endometrial cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well AMG 386 works in treating patients with persistent or recurrent endometrial cancer.
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of AMG 386 (IND# ), a Selective Angiopoietin ½ Neutralizing Peptibody, in Patients With Persistent/Recurrent Carcinoma of the Endometrium|
- Progression-free survival for at least 6 months [ Designated as safety issue: No ]
- Objective tumor response (complete or partial response) [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v 4.0 [ Designated as safety issue: Yes ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
- 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 angiopoietin 1/2-neutralizing peptibody AMG 386 (AMG 386).
- To assess the frequency of objective tumor response in patients treated with this regimen.
- To determine the nature and degree of toxicity of this regimen in these patients.
- To determine the duration of progression-free survival and overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive angiopoietin 1/2-neutralizing peptibody AMG 386 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 therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.