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PARP Inhibitor

Nirapaib for Cervical Cancer (NIVIX Trial)

Phase 1 & 2

Waitlist Available

Led By Michelle S Ludwig, MD, MPH, PhD

Research Sponsored by Michelle S Ludwig

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 end of treatment (8 weeks) and every 3 months during follow-up phase for up to 5 years

Awards & highlights

NIVIX Trial Summary

This trial is testing whether the cancer drug niraparib, when given with radiation therapy, is safe and effective in treating women with metastatic cervical cancer.

Eligible Conditions

Cervical Cancer

NIVIX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment (8 weeks) and every 3 months during follow-up phase for up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of treatment (8 weeks) and every 3 months during follow-up phase for up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (8 weeks) and every 3 months during follow-up phase for 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

Difference in local progression-free survival

Maximum tolerated dose of niraparib

Secondary outcome measures

Change in the quality of life measured using FACT-Cx questionnaire

acute toxicity profile of niraparib

tumor response

NIVIX Trial Design

1Treatment groups

Experimental Treatment

Group I: Niraparib ArmExperimental Treatment1 Intervention

For the purposes of this study, two dose levels of Niraparib (100 mg and 200 mg) will be evaluated concomitant with the concurrent administration of pelvic radiotherapy.

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Who is running the clinical trial?

Michelle S LudwigLead Sponsor

1 Previous Clinical Trials

57 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,753 Previous Clinical Trials

8,069,434 Total Patients Enrolled

Michelle S Ludwig, MD, MPH, PhD5.01 ReviewsPrincipal Investigator - Baylor College of Medicine

Baylor College of Medicine

1 Previous Clinical Trials

57 Total Patients Enrolled

5Patient Review

Dr. Smith is excellent. They are very caring and passionate about their patients, and have a wealth of knowledge.

Frequently Asked Questions

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

What other inquiries have been made into Nirapaib's efficacy?

"At present, Nirapaib is being tested in 99 clinical trials. Of these studies, 13 are at Phase 3 with a majority of them taking place in Washington D.C., although there are over 2800 other sites participating globally."

Answered by AI

Can individuals currently join this medical experiment?

"According to clinicaltrials.gov, this investigative research is actively recruiting. It was initially posted on July 15th 2019 and last modified April 22nd 2021."

Answered by AI

What is the current participation rate for this clinical experiment?

"Affirmative. Clinicaltrials.gov holds records of this medical trial, which was initially launched on July 15th 2019, currently recruiting subjects. 24 individuals need to be recruited from 2 sites for the trial's completion."

Answered by AI

Is this an experimental clinical trial?

"Myriad Genetics, Inc. initiated the first clinical trial of Nirapaib in 2016 with 733 participants and subsequently obtained Phase 3 drug approval. This medication has since been studied extensively; 99 active studies are being conducted amongst 485 cities and 49 countries worldwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix

Michelle S Ludwig 2019. "Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03644342.