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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT05523440
Phase
PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 31, 2022
Start date
Feb 15, 2023
Status verified
May 2026
Primary completion
Jan 8, 2025
Completion
Jan 8, 2025

Study Design

Enrollment
9 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1: Niraparib
    Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
  • Experimental: Arm 2: Niraparib and Bevacizumab
    Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily. Bevacizumab (15 mg/kg, IV on day 1 of each cycle).

Primary Outcome Measure

Proportion of Patients With Objective Response Rate With Recurrent Endometrial Cancer With Mutated ARID1A [ Time Frame: 16 months, until early study termination ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health Sciences Center, Stephenson Cancer CenterOklahoma CityOklahoma73104-
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22903-

Find similar trials in Oklahoma City, OK

By research site
University of Oklahoma Health Sciences Center, Stephenson Cancer Center· Oklahoma City, OKUniversity of Virginia Comprehensive Cancer Center· Charlottesville, VA

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