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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 belowSelect...
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 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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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
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?
University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,564 Total Patients Enrolled
7 Trials studying Endometrial Cancer
341 Patients Enrolled for Endometrial Cancer
GlaxoSmithKlineIndustry Sponsor
4,764 Previous Clinical Trials
8,104,757 Total Patients Enrolled
7 Trials studying Endometrial Cancer
734 Patients Enrolled for Endometrial Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced but localized, and can potentially be cured.I have never been treated with a PARP inhibitor, including niraparib.You are expected to live for more than 12 weeks.I have had a bone marrow or double umbilical cord blood transplant.I am fully active and can carry on all my pre-disease activities without restriction.I cannot take pills by mouth or have stomach issues affecting medication absorption.I haven't had any other cancers in the last 5 years that could affect my survival.I have not had major surgery in the last 4 weeks.I do not have active heart disease or uncontrolled high blood pressure.I've had signs or symptoms of a bowel blockage in the last 6 weeks.I have lasting side effects from cancer treatment, but not hair loss.I have brain metastases that are causing symptoms and are not under control.I have not had bleeding problems or hemorrhagic disorders in the last 6 months.I can take pills and my body can absorb them.Your disease can be measured using specific medical guidelines.My endometrial or ovarian cancer has worsened and has ARID1A mutations.I have a stored sample of my tumor available.I have healed from major surgeries without open wounds or ulcers.I have a history of or signs pointing to myelodysplastic syndrome or acute myeloid leukemia.I am a woman who can have children and I am not pregnant.I have not had radiotherapy in the last 2 weeks.I do not have any serious, uncontrolled health issues or infections.I am a woman aged 18 or older.I have not had a stroke or mini-stroke in the last 6 months.My heart's electrical activity is irregular or I have a family history of long QT syndrome.My cancer has worsened after treatment with a platinum-based drug.My blood, liver, and kidney tests are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Niraparib and Bevacizumab
- Group 2: Arm 1: Niraparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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