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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is for people who are already taking niraparib in other trials and want to keep taking it. The goal is to learn more about the long-term safety of the drug.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Vomiting
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Dehydration
9%
Blood bilirubin increased
9%
Urinary tract infection
9%
Dry mouth
9%
Back pain
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Hypotension
4%
Hyponatremia
4%
Hypokalemia
4%
Depression
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

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
~1540

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,446 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,904 Total Patients Enrolled

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04641247 — Phase 2
Ovarian Tumors Research Study Groups: Participants receiving niraparib
Ovarian Tumors Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT04641247 — Phase 2
Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04641247 — Phase 2

Frequently Asked Questions

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

Is recruitment still ongoing for this research endeavor?

"This study is no longer seeking patients. First published on April 16th 2021 and last updated July 20 2022, this trial has reached its recruitment limit. However, there are 4994 clinical trials available for those with breast cancer and 99 studies employing Niraparib currently accepting enrollees."

Answered by AI

To what extent is Niraparib an issue of potential hazard?

"Niraparib's safety has been assessed at level 2 due to the limited clinical data available, as we are currently in phase 2 of this trial and efficacy is yet to be determined."

Answered by AI

Does this experimental trial represent a pioneering effort in its field?

"Since 2016, researchers have been investigating the potential of Niraparib. In that same year Myriad Genetics Inc. launched a Phase 1 trial with 733 participants which eventually led to full drug approval for this medication in the third stage of clinical trials. As we speak, there are 99 active experiments employing Niraparib taking place around the globe spanning 49 nations and 485 cities."

Answered by AI

How many volunteers have signed up to participate in this trial?

"At the present moment, this clinical trial is not seeking new participants. It was first made available on April 16th 2021 and last altered on July 20th 2022. However, if you are looking for other trials related to breast cancer there presently 4944 studies that need volunteers; 99 of them being Niraparib-related."

Answered by AI

How widespread is the availability of this clinical trial?

"Currently, the medical trial is open for enrollment in 14 sites across North America. Tucson, Montreal and Vancouver are some of these locales with several more located close to you; therefore it's pertinent to pick a place that'll reduce transport needs if one decides to participate."

Answered by AI

Are there any additional investigations that have utilized Niraparib?

"Currently, there are 99 Niraparib-related studies in progress. Of these medical investigations, 13 have advanced to phase 3 trials. The majority of the research is conducted in Washington District of Columbia but a total of 2816 sites are involved with this treatment's evaluation."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study
2021. "A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04641247.
All > Breast Cancer High Point > Ovarian Cancer
~9 spots leftby Nov 2025
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