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PARP Inhibitor

Niraparib + Panitumumab for Colorectal Cancer (NIPAVect Trial)

Phase 2
Waitlist Available
Led By Olatunji Alese, MD
Research 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 an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Histologic or cytologic diagnosis of colorectal cancer
Must not have
Participant must not have known active, symptomatic brain or leptomeningeal metastases.
Participant has had radiation therapy encompassing > 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects include typical reactions from immune therapies like skin rash, fatigue, diarrhea as well as those related to enzyme inhibitors such as nausea and low blood cell counts which could lead to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all pre-disease activities without restriction.
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My diagnosis is colorectal cancer confirmed by lab tests.
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My kidney function, measured by creatinine levels, is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active brain or spinal cord cancer symptoms.
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I haven't had significant radiation therapy affecting my bone marrow recently.
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I have been diagnosed with HIV.
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I have previously been treated with PARP or EGFR inhibitors for cancer.
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I cannot take medications by mouth.
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I am not allergic to niraparib or panitumumab.
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I haven't had any cancer treatments, except for skin or treated cervical cancer, in the last 2 years.
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I do not have any serious health issues that are not under control.
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I have had or currently have lung scarring or inflammation.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical benefit rate (CBR)
Secondary study objectives
Duration of response (DOR)
Objective response rate (ORR)
Overall survival (OS)
+1 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
22%
Dyspnea
17%
Headache
17%
Mucositis oral
17%
Platelet count decreased
17%
Creatinine increased
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
13%
Sinus tachycardia
9%
Cough
9%
Dehydration
9%
Urinary tract infection
9%
Dry mouth
9%
Hypertension
9%
Non-cardiac chest pain
9%
Alanine aminotransferase increased
9%
Anxiety
9%
Blood bilirubin increased
9%
Back pain
4%
Upper respiratory infection
4%
Hoarseness
4%
Hypotension
4%
Hot flashes
4%
Postnasal drip
4%
Head injury
4%
Hypokalemia
4%
Hyponatremia
4%
Flu like symptoms
4%
Skin tear
4%
Hyperglycemia
4%
Neutrophil count decreased
4%
Tremor
4%
Bruising
4%
Esophageal ulcer
4%
Diarrhea
4%
Depression
4%
Itchy eyes
4%
Oral petechia
4%
Edema limbs
4%
Hyperkalemia
4%
Peripheral sensory neuropathy
4%
Leukocytosis
4%
White blood cell decreased
4%
Lung infection
4%
Bloating
4%
Unknown infection
4%
Hematuria
4%
Ascites
4%
Sinus pain
4%
Sore throat
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Awards & Highlights

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
2017
Completed Phase 3
~7150
Niraparib
2018
Completed Phase 4
~2400

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
PARP inhibitors, such as Niraparib, work by blocking the PARP enzyme, which is crucial for repairing DNA damage in cancer cells. This inhibition leads to the accumulation of DNA damage, ultimately causing cancer cell death, particularly in cells with existing DNA repair defects. EGFR inhibitors, like Panitumumab, target the epidermal growth factor receptor (EGFR) on the surface of cancer cells, blocking the signals that promote cell growth and survival. This inhibition can slow down or stop the proliferation of cancer cells. These mechanisms are significant for colorectal cancer patients as they offer targeted treatment options that can be more effective and potentially have fewer side effects compared to traditional chemotherapy.
Vulnerability to low-dose combination of irinotecan and niraparib in ATM-mutated colorectal cancer.The poly(ADP-ribose) polymerase inhibitor niraparib (MK4827) in BRCA mutation carriers and patients with sporadic cancer: a phase 1 dose-escalation trial.

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,701 Previous Clinical Trials
2,604,691 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,808 Previous Clinical Trials
8,381,338 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,818 Previous Clinical Trials
8,161,655 Total Patients Enrolled

Media Library

Niraparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03983993 — Phase 2
Colon Cancer Research Study Groups: Treatment (niraparib, panitumumab)
Colon 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
~7 spots leftby Dec 2025