Recruitment

Recruitment Status
Completed
Estimated Enrollment
55

Summary

Conditions
  • Endometrial Adenocarcinoma
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Mucinous Adenocarcinoma
  • Endometrial Serous Adenocarcinoma
  • Endometrial Squamous Cell Carcinoma
  • Endometrial Transitional Cell Carcinoma
  • Endometrial Undifferentiated Carcinoma
  • Malignant Uterine Corpus Mixed Epithelial and Mesenchymal Neoplasm
  • Recurrent Uterine Corpus Carcinoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

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 pa...

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.

Tracking Information

NCT #
NCT01225887
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Don Dizon NRG Oncology