What side effects are associated with this type of intervention?

The most common treatments for endometrial cancer, such as Niraparib (a PARP inhibitor) and Bevacizumab (an anti-angiogenic agent), have distinct side effect profiles. Niraparib can cause anemia, thrombocytopenia, constipation, vomiting, mucositis, fatigue, decreased appetite, headache, insomnia, nasopharyngitis, dyspnea, rash, and hypertension, with a risk of myelodysplastic syndrome and acute myeloid leukemia. Bevacizumab is associated with hypertension, proteinuria, bleeding, thromboembolic events, gastrointestinal perforations, and wound healing complications. Patients should discuss these potential side effects with their healthcare provider to make an informed treatment decision.

What prior FDA approvals exist?

The FDA has approved several treatments for endometrial cancer, including targeted therapies similar to those being studied in the trial involving niraparib and bevacizumab. Niraparib, a PARP inhibitor, has been approved for use in ovarian cancer and is being explored for its efficacy in endometrial cancer. Bevacizumab, an anti-angiogenic agent, has also been approved for various cancers, including ovarian cancer, and is under investigation for its potential benefits in endometrial cancer. These drugs work by targeting specific pathways involved in cancer cell survival and proliferation, offering a more tailored approach to treatment.

What other types of research exist?

Promising novel alternatives for endometrial cancer treatment include the combination of pembrolizumab (an immune checkpoint inhibitor) and lenvatinib (a VEGF receptor inhibitor), which has shown significant improvements in progression-free survival and overall survival in patients with advanced endometrial cancer. Additionally, dovitinib (a fibroblast growth factor receptor inhibitor) and NVP-BGJ398 are under evaluation for their efficacy in FGFR2-mutated endometrial cancer and may offer broader applicability beyond specific mutations.

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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

Must not have

Any previous treatment with PARP inhibitor, including niraparib

Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if a combination of niraparib and bevacizumab can help patients with recurrent endometrial or ovarian cancer. Niraparib is a pill that stops cancer cells from repairing themselves, and bevacizumab is a drug that prevents tumors from getting the blood they need to grow. Bevacizumab has been studied extensively in combination with other treatments for various types of cancer, including ovarian and endometrial cancers.

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.

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.

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.

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never been treated with a PARP inhibitor, including niraparib.

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I have had a bone marrow or double umbilical cord blood transplant.

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I cannot take pills by mouth or have stomach issues affecting medication absorption.

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I haven't had any other cancers in the last 5 years that could affect my survival.

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I have not had major surgery in the last 4 weeks.

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I do not have active heart disease or uncontrolled high blood pressure.

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I have lasting side effects from cancer treatment, but not hair loss.

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I have brain metastases that are causing symptoms and are not under control.

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I have a history of or signs pointing to myelodysplastic syndrome or acute myeloid leukemia.

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I do not have any serious, uncontrolled health issues or infections.

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My heart's electrical activity is irregular or I have a family history of long QT syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Duration of Response

Incidence of Adverse Events

Progression Free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5540

Niraparib

2018

Completed Phase 4

~2400

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

PARP inhibitors like Niraparib block the PARP enzyme, preventing the repair of DNA damage in cancer cells, which leads to cell death, especially in cells with defective homologous recombination repair. Bevacizumab, an anti-angiogenic agent, inhibits VEGF, reducing the blood supply to tumors and thereby inhibiting their growth and spread. These treatments are significant for endometrial cancer patients as they target specific pathways essential for cancer cell survival and proliferation, offering more effective and targeted therapeutic options.

Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial.Major clinical research advances in gynecologic cancer in 2016: 10-year special edition.