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Angiogenesis Inhibitor

Bevacizumab + Niraparib for Ovarian and Endometrial Cancer (ARID1A Trial)

Phase 2
Recruiting
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have an ECOG performance status of ≤ 1
Able to swallow, absorb, retain oral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

ARID1A Trial Summary

This trial tests how well a combo of two drugs treat ovarian or endometrial cancer with an ARID1A mutation. Effects are studied.

Who is the study for?
This trial is for women over 18 with recurrent endometrial or ovarian cancer and ARID1A mutation. They must not be pregnant, have a life expectancy over 12 weeks, and able to take oral medication. Participants need measurable disease by RECIST v1.1, good organ function, ECOG ≤ 1, and recovery from major surgery without open wounds.Check my eligibility
What is being tested?
The study tests the tumor response to niraparib combined with bevacizumab in patients with specific recurrent cancers. It aims to understand the effectiveness and side effects of this treatment combination in those who've had prior platinum-based therapy.See study design
What are the potential side effects?
Potential side effects may include high blood pressure issues related to bevacizumab and bone marrow suppression or gastrointestinal symptoms due to niraparib. Other risks could involve bleeding disorders or heart problems.

ARID1A Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all my pre-disease activities without restriction.
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I can take pills and my body can absorb them.
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My endometrial or ovarian cancer has worsened and has ARID1A mutations.
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I have a stored sample of my tumor available.
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I have healed from major surgeries without open wounds or ulcers.
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I am a woman who can have children and I am not pregnant.
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I am a woman aged 18 or older.
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My cancer has worsened after treatment with a platinum-based drug.
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My blood, liver, and kidney tests are within normal ranges.

ARID1A Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients with objective response rate with recurrent endometrial cancer with mutated ARID1A
Proportion of patients with objective response rate with recurrent ovarian cancer with mutated ARID1A
Secondary outcome measures
Duration of Response
Incidence of Adverse Events
Progression Free Survival

ARID1A Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2: Niraparib and BevacizumabExperimental Treatment2 Interventions
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).
Group II: Arm 1: NiraparibActive Control1 Intervention
Niraparib (200mg or 300 mg based on body weight and blood platelet count), oral, once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Niraparib
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineIndustry Sponsor
4,748 Previous Clinical Trials
8,067,420 Total Patients Enrolled
7 Trials studying Endometrial Cancer
734 Patients Enrolled for Endometrial Cancer
University of OklahomaLead Sponsor
455 Previous Clinical Trials
98,209 Total Patients Enrolled
7 Trials studying Endometrial Cancer
341 Patients Enrolled for Endometrial Cancer

Media Library

Bevacizumab (Angiogenesis Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05523440 — Phase 2
Endometrial Cancer Research Study Groups: Arm 2: Niraparib and Bevacizumab, Arm 1: Niraparib
Endometrial Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT05523440 — Phase 2
Bevacizumab (Angiogenesis Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05523440 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any new volunteers being accepted for this clinical trial?

"According to the clinicaltrials.gov listing, this trial is currently selecting participants. Initially posted on February 1st of 2023, it was most recently updated 6 days later."

Answered by AI

Has the FDA authorized Arm 2: Niraparib and Bevacizumab?

"According to our in-house assessment, the safety of Arm 2: Niraparib and Bevacizumab is rated at a 2. This is as there has been some data collected on its safety but none confirming efficacy."

Answered by AI

What is the maximum capacity for participants in this trial?

"Affirmative. According to clinicaltrials.gov, this medical study initially posted on February 1st 2023 is currently enrolling participants. 92 individuals are being recruited from a single site for the trial's duration."

Answered by AI
~57 spots leftby Jan 2026