Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer
Last updated on July 2021Recruitment
- 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