← Back to Search

PARP Inhibitor

Niraparib Tablet for Tumors

Phase 1

Waitlist Available

Research Sponsored by Tesaro, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1 year

Awards & highlights

Study Summary

This trial is testing a new tablet form of niraparib compared to the current capsule form. The effects of a high-fat meal on niraparib are also being evaluated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Apparent terminal volume of distribution for niraparib-Stages 1, 2 and 3 PK Phase

Apparent total body clearance for niraparib-Stages 1, 2 and 3 PK Phase

Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0 to inf]) for niraparib-Stages 1, 2 and 3 PK Phase

+5 more

Secondary outcome measures

Number of participants with TEAEs, serious TEAEs and discontinuations due to TEAEs-Extension Phase

Number of participants with treatment emergent adverse events (TEAEs), serious TEAEs and discontinuations due to TEAEs-Stages 1, 2 and 3 PK Phase

Trial Design

6Treatment groups

Experimental Treatment

Group I: Stage 3: High fat meal-fasted sequenceExperimental Treatment1 Intervention

Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state.

Group II: Stage 3: Fasted-high fat meal sequenceExperimental Treatment1 Intervention

Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.

Group III: Stage 2: Tablet-Capsule SequenceExperimental Treatment2 Interventions

Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase.

Group IV: Stage 2: Capsule-Tablet SequenceExperimental Treatment2 Interventions

Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase

Group V: Stage 1: Tablet-Capsule SequenceExperimental Treatment2 Interventions

Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase

Group VI: Stage 1: Capsule-Tablet SequenceExperimental Treatment2 Interventions

Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor

56 Previous Clinical Trials

10,320 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,694 Total Patients Enrolled

1 Trials studying Tumors

12 Patients Enrolled for Tumors

Frequently Asked Questions

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

What is the number of medical centers actively conducting this trial?

"Currently, the trial is running in 9 different cities including San Marcos, Grand Rapids and New Haven. To reduce travel time if participating, it would be most prudent to select a location that's close by."

Answered by AI

Could you provide a comprehensive overview of research trials involving Niraparib Tablet?

"At present, there are 99 ongoing clinical trials centred around Niraparib Tablet with 13 in the Phase 3 phase. Most of these experiments take place in Washington DC but 2817 medical centres across the world provide locations for testing this medication."

Answered by AI

What is the safety profile of taking Niraparib Tablet?

"Niraparib Tablet has only limited data backing up its efficacy and safety, so it got a rating of 1 on the Power team's scale."

Answered by AI

Is this investigation open to participation at the moment?

"Clinicaltrials.gov states that this research is no longer recruiting patients, although it was first posted on November 29th 2017 and last updated September 7th 2022. In contrast to this trial, there are 2479 other studies actively enrolling volunteers at the present moment in time."

Answered by AI

What is the maximum capacity for enrollees in this trial?

"This medical trial is not presently enrolling new participants. It initially went public on the 29th of November, 2017 with an update posted to it on the 7th of September, 2022. However, 2380 cancer-related trials and 99 Niraparib Tablet studies are currently searching for people who meet their criteria."

Answered by AI

Is this research an unprecedented endeavor?

"Since 2016, Myriad Genetics Inc. has been researching the efficacy of Niraparib Tablet, with the first trial being completed in that same year. Following this initial exploration involving 733 participants, it was granted Phase 3 drug approval and is today under investigation by 99 active trials spanning 49 countries and 485 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule

2017. "Crossover Study to Assess the Relative Bioavailability and Bioequivalence of Niraparib Tablet Compared to Niraparib Capsule". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03329001.