~4 spots leftby Apr 2026

Niraparib + Panitumumab for Colorectal Cancer

(NIPAVect Trial)

Recruiting in Palo Alto (17 mi)
+2 other locations
OA
Overseen byOlatunji Alese, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Emory University
No Placebo Group
Prior Safety Data
Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial studies how well niraparib and panitumumab work together in treating patients with advanced colorectal cancer who have already received treatment. Niraparib blocks enzymes needed for cancer growth, while panitumumab helps the immune system attack cancer cells and stops them from spreading. Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is used in the treatment of metastatic colorectal cancer, particularly in patients with wild-type KRAS tumors.

Research Team

OA

Olatunji Alese, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for adults with advanced colorectal cancer that has spread, who have tried at least one systemic therapy. They must be in good physical condition (ECOG ≤ 1), have adequate blood counts and organ function, and not be pregnant or fathering a child. Those with prior treatment using PARP or EGFR inhibitors, active brain metastases, known hypersensitivity to the drugs being tested, or other serious health issues are excluded.

Inclusion Criteria

I've had chemotherapy before and either it didn't work, I couldn't tolerate it, or I'm currently on a stable first line treatment.
I am fully active and can carry on all pre-disease activities without restriction.
I agree to use birth control from the start of the study until 6 months after it ends.
See 11 more

Exclusion Criteria

I do not have active brain or spinal cord cancer symptoms.
Participant must not be simultaneously enrolled in any interventional clinical trial
I haven't had significant radiation therapy affecting my bone marrow recently.
See 7 more

Treatment Details

Interventions

  • Niraparib (PARP Inhibitor)
  • Panitumumab (Monoclonal Antibodies)
Trial OverviewThe trial is testing the combination of niraparib (an enzyme inhibitor) and panitumumab (a monoclonal antibody immunotherapy) on patients with RAS wildtype colorectal cancer. The goal is to see if this drug duo can better halt tumor growth compared to current treatments.
Participant Groups
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.

Niraparib is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Zejula for:
  • Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+
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Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

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Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

GlaxoSmithKline

Industry Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+
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Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

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Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

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Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School