NCT05523440

Bevacizumab and/or Niraparib in Patients With Recurrent Endometrial and/or Ovarian Cancer With ARID1A Mutation

Phase 2 Trial of Niraparib or Niraparib and Bevacizumab Combination in Patients With Recurrent Endometrial Cancer and/or Ovarian Cancer With ARID1A Mutation (OU-SCC-ARID1A)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test the proportion of tumor response to the combination treatment with niraparib and bevacizumab and see what effects (good and bad) this combination treatment has on patients with recurrent endometrial or ovarian cancer with ARID1A mutation.

Detailed description

Patients will have tests and exams to see if they are eligible for the clinical trial. If found eligible, the patient will be randomized into one of two groups and receive treatment as follows: If patients are in the first group,they will receive niraparib alone, once daily taken by mouth. If patients are in the second group, they will receive niraparib once daily taken by mouth and infusion of bevacizumab once every 3 weeks. Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable, bad side effects. Patients will be monitored during treatment with tests and exams and after treatment completion for up to 3 years.

Conditions

• Recurrent Endometrial Carcinoma
• Recurrent Ovarian Carcinoma
• ARID1A Gene Mutation

Interventions

Type	Name	Description
DRUG	Bevacizumab	Bevacizumab infusion.
DRUG	Niraparib	Niraparib oral capsule.

Timeline

• Start date: 2023-02-15
• Primary completion: 2025-01-08
• Completion: 2025-01-08
• First posted: 2022-08-31
• Last updated: 2025-03-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study