What side effects are associated with this type of intervention?

Common treatments for ovarian tumors, particularly PARP inhibitors like Niraparib, often have side effects such as anemia, thrombocytopenia (low platelet count), and neutropenia (low neutrophil count). Other side effects may include nausea, fatigue, and gastrointestinal issues like diarrhea. Additionally, treatments like bevacizumab can cause hypertension and proteinuria, while pazopanib is associated with hypertension, diarrhea, and hepatotoxicity. These side effects are important considerations for patients undergoing treatment for ovarian tumors.

What prior FDA approvals exist?

The FDA has approved several PARP inhibitors for the treatment of ovarian tumors, particularly in cases of recurrent or platinum-sensitive ovarian cancer. Niraparib, a PARP inhibitor, is approved for maintenance therapy in patients with recurrent ovarian cancer who have responded to platinum-based chemotherapy. Other PARP inhibitors include olaparib and rucaparib. Olaparib is approved for maintenance treatment in patients with BRCA-mutated advanced ovarian cancer, while rucaparib is approved for both treatment and maintenance therapy in recurrent ovarian cancer. These approvals highlight the role of PARP inhibitors in extending progression-free survival in ovarian cancer patients.

What other types of research exist?

Promising alternatives to Niraparib for ovarian tumor patients include Olaparib and Rucaparib, both of which are PARP inhibitors with demonstrated efficacy in clinical trials. Additionally, combination therapies such as Cediranib with Olaparib have shown potential. Investigational options like heated intraperitoneal chemotherapy (HIPEC) and other targeted therapies may also be considered.

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PARP Inhibitor

Long-term Niraparib for Cancer

Phase 2

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline/TESARO-sponsored study that has fulfilled the requirements for the primary objective.

Be older than 18 years old

Must not have

Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial provides continued access to niraparib for patients already receiving it in certain studies and aims to understand its ongoing safety. Niraparib helps stop cancer cells from repairing their DNA, which can kill the cancer. Niraparib is approved for use in ovarian cancer patients who respond to specific treatments.

Who is the study for?

This trial is for individuals already participating in certain GlaxoSmithKline/TESARO-sponsored studies of Niraparib, who are seeing benefits from the treatment. They must be able to follow the study plan and agree to use effective contraception if they can have children. Pregnant or breastfeeding individuals, those planning to conceive, or with unresolved toxicities from previous Niraparib treatments cannot join.

What is being tested?

The trial provides continued access to Niraparib for participants benefiting from it in prior related studies. It aims to gather more data on the long-term safety of this cancer medication when used by patients with tumors, breast cancer, or ovarian tumors.

What are the potential side effects?

While not specified here, common side effects of Niraparib may include nausea, fatigue, blood cell count changes leading to anemia or risk of infection, heart palpitations, insomnia and constipation. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently on niraparib treatment in a GlaxoSmithKline/TESARO study.

Exclusion Criteria

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

Select...

I was taken off niraparib treatment for any reason.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Number of participants with adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI)

Number of participants with clinically significant changes in Eastern Co-operative Oncology Group (ECOG) performance status

Number of participants with clinically significant changes in hematology and clinical chemistry parameters

+3 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347

74%

Fatigue

52%

Nausea

39%

Constipation

39%

Anorexia

30%

Anemia

30%

Alkaline phosphatase increased

26%

Weight loss

22%

Dizziness

22%

Insomnia

22%

Dyspnea

22%

Abdominal pain

17%

Headache

17%

Mucositis oral

17%

Platelet count decreased

17%

Creatinine increased

13%

Vomiting

13%

Rash maculo-papular

13%

Aspartate aminotransferase increased

13%

Sinus tachycardia

Urinary tract infection

Cough

Dehydration

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Postnasal drip

Hoarseness

Hypotension

Hot flashes

Peripheral sensory neuropathy

Hyperkalemia

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Skin tear

Hyperglycemia

Neutrophil count decreased

Tremor

Bruising

Esophageal ulcer

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Upper respiratory infection

Leukocytosis

White blood cell decreased

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort B

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants receiving niraparibExperimental Treatment1 Intervention

Participants will receive niraparib once a day, continuously throughout each 90-day cycle until one of the following occurs: disease progression, unacceptable toxicity, initiation of new anticancer therapy that was not part of the parent study, withdrawal of consent, discontinuation at the discretion of the Investigator, noncompliance with protocol, death, or discontinuation for any other reason. The doses provided in this long-term treatment extension study will be those defined in the parent study for each enrolled participant. The starting dose of niraparib will be the same as the assigned dose and regimen that were given in the parent study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~2400

0 / 2Eligibility 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

The most common treatments for ovarian tumors include PARP inhibitors, angiogenesis inhibitors, and platinum-based chemotherapies. PARP inhibitors, such as Niraparib, work by blocking the PARP enzyme, which helps repair DNA damage in cells. This is particularly effective in cancer cells with BRCA mutations, leading to cell death and reduced tumor growth. Angiogenesis inhibitors, like bevacizumab, prevent the formation of new blood vessels that tumors need to grow and spread. Platinum-based chemotherapies, such as carboplatin, cause DNA damage that cancer cells cannot repair, leading to cell death. These treatments are crucial for ovarian tumor patients as they target the cancer cells' ability to repair and sustain themselves, thereby improving survival rates and quality of life.