Niraparib for Ovarian Tumors

GSK Investigational Site, Albany, NY
Ovarian TumorsNiraparib - Drug
What conditions do you have?

Study Summary

This trial will test the safety and efficacy of niraparib, an oral inhibitor of PARP-1 and PARP-2, when combined with bevacizumab as maintenance treatment for advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Eligible Conditions
  • Ovarian Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 30 Secondary · Reporting Duration: Upto 3 years

At 18 months
Progression Free Survival (PFS) Rate
Progression free survival (PFS) rate
Year 3
Change From Baseline in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
Year 3
Change from Baseline in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI) - Patient Reported Outcome (PRO)
Change from Baseline in activated partial thromboplastin time (seconds)
Change from Baseline in albumin and total protein levels (gram per Liter)
Alanine Transaminase
Change from Baseline in differential white blood cell count (percentage)
Change from Baseline in hemoglobin (grams per deciliter)
Change from Baseline in mean corpuscular volume (MCV) (picograms)
Change from Baseline in neutrophil count, lymphocyte count, monocyte count, eosinophil count, basophil count and platelet count (giga cells per Liter)
Change from Baseline in sodium, potassium, calcium magnesium, chloride,glucose, and blood urea nitrogen (BUN) levels (millimoles per liter)
Change from Baseline in total bilirubin and creatinine levels (micromoles per Liter)
Year 3
Change from Baseline in International normalized ratio
Change from Baseline in eastern cooperative oncology group (ECOG) performance status
Up to 3 years
Overall Survival (OS)
Progression Free Survival by RECIST v 1.1
RECIST or Cancer Antigen (CA)-125 Progression Free Survival
Time to First Subsequent Therapy (TFST)
Time to Second Subsequent Therapy (TSST)
Month 68
Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs)
Number of Participants With TEAEs Leading to Niraparib Dose Reductions
Number of Participants With TEAEs Leading to Niraparib Treatment Discontinuation
Upto 3 years
Number of participants receiving concomitant medications
Number of participants with AEs leading to discontinuation
Number of participants with abnormal physical examination.
Number of participants with abnormal vital signs
Number of participants with dose reduction due to AEs
Number of participants with serious adverse events (SAEs)
Number of participants with treatment-emergent adverse events (TEAEs)
PFS by RECIST v 1.1
RECIST or cancer antigen (CA)-125 PFS

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
52%Decreased appetite
24%Oedema peripheral
24%Platelet count decreased
19%Blood alkaline phosphatase increased
14%Weight decreased
14%Upper respiratory tract infection
14%Neutrophil count decreased
14%Back pain
14%Muscular weakness
10%Productive cough
10%Gait disturbance
10%Urinary tract infection
10%Non-cardiac chest pain
10%Alanine aminotransferase increased
10%Chest pain
10%Pleural effusion
10%Atrial fibrillation
10%Haemorrhoidal haemorrhage
10%Oropharyngeal pain
10%Aspartate aminotransferase increased
10%Blood creatinine increased
10%Lymphocyte count decreased
10%Neuropathy peripheral
10%Rash maculo-papular
10%Pain of skin
10%Vision blurred
5%Candida infection
5%Toxicity to various agents
5%Angina pectoris
5%Gastrooesophageal reflux disease
5%Cancer pain
5%Peripheral sensory neuropathy
5%Neuroendocrine carcinoma of the skin
5%Pulmonary embolism
5%Hepatic enzyme increased
5%Lipase increased
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Abdominal pain
5%Nasal congestion
5%Amylase increased
5%Pain in extremity
5%Sinus tachycardia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03308942) in the Stage 1 (Cohort 2): Niraparib + Pembrolizumab ARM group. Side effects include: Nausea with 57%, Decreased appetite with 52%, Constipation with 48%, Anaemia with 48%, Fatigue with 43%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Participants receiving niraparib+ bevacizumab
1 of 1

Experimental Treatment

105 Total Participants · 1 Treatment Group

Primary Treatment: Niraparib · No Placebo Group · Phase 2

Participants receiving niraparib+ bevacizumabExperimental Group · 2 Interventions: Niraparib, Bevacizumab · Intervention Types: Drug, Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: upto 3 years

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
10,574 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,573 Previous Clinical Trials
6,137,188 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

What condition is Niraparib usually utilized to address?

"Patients with malignant growths, recurrent platinum-sensitive primary peritoneal cancer, and Stage IV epithelial ovarian cancer after initial surgical excision can benefit from Niraparib therapy." - Anonymous Online Contributor

Unverified Answer

Has Niraparib been authorized by the Food and Drug Administration?

"Niraparib's safety has been attested to through Phase 2 trials, thus it earned a score of 2 on our scale. However, the efficacy of this treatment has yet to be sufficiently demonstrated." - Anonymous Online Contributor

Unverified Answer

Could you elucidate on other experiments that have included Niraparib?

"Back in 2004, Niraparib was first investigated at Memorial Sloan Kettering Basking Ridge (Follow Up Only). Since then, 1027 clinical trials have been concluded. 446 separate studies are still ongoing, with a considerable amount of them centered around Englewood, New Jersey." - Anonymous Online Contributor

Unverified Answer

What are the core goals this clinical trial is trying to achieve?

"The primary outcome of this 18 month trial will be the Progression Free Survival (PFS) Rate. Secondary metrics include Number of participants with abnormal vital signs, Change from Baseline in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI) - Patient Reported Outcome (PRO), and finally, Number of participants with dose reduction due to Adverse Events." - Anonymous Online Contributor

Unverified Answer

How many healthcare establishments are administering this research in the metropolis?

"The trial is currently operational in 28 medical centres - including Englewood, Lebanon and Providence - so participants are encouraged to choose the site that's closest to them. This will help reduce commuting needs if they decide to join." - Anonymous Online Contributor

Unverified Answer

How much interest has been generated in this research endeavor?

"Unfortunately, this clinical trial is not presently accepting candidates. First posted on December 12th 2017, the study has since been edited for the last time on November 23rd 2021. However, if you are looking to join a medical trial related to ovarian cancer there are currently 535 active studies and 446 trials focusing on Niraparib that require participants." - Anonymous Online Contributor

Unverified Answer

Is recruitment of participants still underway for this experiment?

"Currently, this clinical trial is not actively recruiting participants. After first being posted on December 12th 2017 and most recently updated on November 23rd 2022, there are no open roles available at the moment. However, if you're interested in other studies related to ovarian cancer or Niraparib treatments specifically, 535 and 446 trials respectively are seeking new enrolments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.