PARP Inhibitor

Niraparib for Colorectal Cancer

Q: Are there previous investigations concerning Niraparib?

<p>As of now, 131 clinical tri<a href="https://www.withpower.com/clinical-trials/als">als</a> are in progress for Niraparib. 16 of these studies are currently at Phase 3 and there is a total of 3374 sites hosting the research. The bulk of these investigations take place within Washington D.C., however other locations across the United States also offer access to these resources.</p>

Q: Has the Drug and Food Administration sanctioned the use of Niraparib?

<p>The safety of ni<a href="https://www.withpower.com/clinical-trials/ra">ra</a>parib was rated a 2 on our scale, as although there is some evidence confirming its security, no data exists to display the efficacy.</p>

Emory Saint Joseph's Hospital, Atlanta, GA

Targeting 6 different conditionsNiraparib +1 morePhase 2Waitlist AvailableLed by Olatunji Alese, MDResearch Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Participant must have advanced, metastatic RAS wildtype colorectal cancer and must have received at least one line of systemic therapy. Both microsatellite (MSI) high and stable (MSS) patients are eligible

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 5 years post treatment

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Study Summary

This trial is testing niraparib and panitumumab to see if they're effective at treating colorectal cancer.

Eligible Conditions

Metastatic Microsatellite Stable Colorectal Cancer
Colorectal Carcinoma
Microsatellite Stability
RAS Wild Type
Colorectal Cancer

Eligibility Criteria

Inclusion Criteria

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

Select...

You have advanced colorectal cancer that has spread to other parts of your body and does not have specific gene mutations. You have already received at least one type of treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years post treatment

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

Treatment Details

Study Objectives

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

Primary outcome measures

Clinical benefit rate (CBR)

Secondary outcome measures

Duration of response (DOR)

Objective response rate (ORR)

Overall survival (OS)

+1 more

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-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (niraparib, panitumumab)Experimental Treatment2 Interventions

Patients receive 200 or 300 mg niraparib orally once daily on days 1-28 and 6 mg/kg panitumumab intravenously over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Panitumumab

FDA approved

Niraparib

FDA approved

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,585 Previous Clinical Trials

2,882,388 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,704 Previous Clinical Trials

8,046,801 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,611 Previous Clinical Trials

6,663,298 Total Patients Enrolled

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03983993 — Phase 2

Colorectal Cancer Research Study Groups: Treatment (niraparib, panitumumab)

Colorectal Cancer Clinical Trial 2023: Niraparib Highlights & Side Effects. Trial Name: NCT03983993 — Phase 2

Niraparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03983993 — Phase 2

Frequently Asked Questions

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

Is there an ongoing recruitment effort for this clinical experiment?

"As evidenced on clinicaltrials.gov, this study is currently recruiting volunteers and was first made available to the public in October of 2019 with its most recent update occurring November 1st 2022."

Answered by AI

How many participants have enrolled in this clinical investigation?

"Affirmative. As indicated by clinicaltrials.gov, this medical investigation is currently seeking volunteers; first posted on October 15th 2019 and last updated November 1st 2022. 40 participants have to be sourced from 3 locations for the trial's completion."

Answered by AI

Are there previous investigations concerning Niraparib?

"As of now, 131 clinical trials are in progress for Niraparib. 16 of these studies are currently at Phase 3 and there is a total of 3374 sites hosting the research. The bulk of these investigations take place within Washington D.C., however other locations across the United States also offer access to these resources."

Answered by AI

Has the Drug and Food Administration sanctioned the use of Niraparib?

"The safety of niraparib was rated a 2 on our scale, as although there is some evidence confirming its security, no data exists to display the efficacy."

Answered by AI

Is this an unprecedented medical experiment?

"Amgen first initiated the research of niraparib in 2011 and, following a successful Phase 1 trial involving 75 patients, granted it approval for Phase 2 testing. Currently there are 131 active trials occurring across 561 cities within 50 countries."

Answered by AI

What has been the primary focus of research involving Niraparib?

"Niraparib is primarily utilized to address primary peritoneal cancer, yet it can also be employed in the treatment of metastatic colorectal cancer (crc), fallopian tubes carcinoma, and other malignancies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Olatunji Alese 2019. "Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03983993.

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