Trials / Completed

CompletedNCT01225887

Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer

A Phase II Evaluation of BIBF 1120 in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 37 (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 nintedanib works in treating patients with endometrial cancer that has come back. Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or 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 without going on a subsequent therapy against the disease for at least 6 months and the proportion of patients who have objective tumor response (complete or partial), treated with BIBF 1120 (nintedanib). II. To determine the nature and degree of toxicity of BIBF 1120 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 BIBF 1120. OUTLINE: Patients receive nintedanib orally (PO) twice daily (BID) on days 1-28. 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

Type	Name	Description
DRUG	Nintedanib	Given PO

Timeline

Start date: 2011-10-01
Primary completion: 2016-01-01
Completion: 2016-01-01
First posted: 2010-10-21
Last updated: 2017-10-09
Results posted: 2017-10-09

Locations

59 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01225887. Inclusion in this directory is not an endorsement.