What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as PARP inhibitors (e.g., Niraparib) and EGFR inhibitors (e.g., Panitumumab), have distinct side effect profiles. PARP inhibitors often cause nausea, fatigue, anemia, and thrombocytopenia. On the other hand, EGFR inhibitors are frequently associated with skin rash, diarrhea, and hypomagnesemia. Patients undergoing these treatments should be monitored for these adverse effects to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for colorectal cancer, including EGFR inhibitors like Panitumumab, which is used for metastatic colorectal cancer with wild-type RAS. While PARP inhibitors like Niraparib are primarily approved for ovarian and other cancers, their use in colorectal cancer is still under investigation. Other approved treatments for colorectal cancer include chemotherapy agents such as fluorouracil, oxaliplatin, and targeted therapies like bevacizumab.

What other types of research exist?

Promising novel alternatives for colorectal cancer treatment in 2024 include immunotherapy agents such as pembrolizumab (PD-1 inhibitor) and nivolumab (PD-1 inhibitor), as well as targeted therapies like bevacizumab (VEGF inhibitor) and regorafenib (multi-kinase inhibitor). These agents have shown efficacy in clinical trials and offer different mechanisms of action compared to Niraparib and Panitumumab.

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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 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

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%

Dizziness

22%

Insomnia

22%

Dyspnea

22%

Abdominal pain

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

Urinary tract infection

Cough

Dehydration

Dry mouth

Hypertension

Non-cardiac chest pain

Alanine aminotransferase increased

Anxiety

Blood bilirubin increased

Back pain

Postnasal drip

Hoarseness

Hypotension

Hot flashes

Peripheral sensory neuropathy

Hyperkalemia

Head injury

Hypokalemia

Hyponatremia

Flu like symptoms

Skin tear

Hyperglycemia

Neutrophil count decreased

Tremor

Bruising

Esophageal ulcer

Diarrhea

Depression

Itchy eyes

Oral petechia

Edema limbs

Upper respiratory infection

Leukocytosis

White blood cell decreased

Lung infection

Bloating

Unknown infection

Hematuria

Ascites

Sinus pain

Sore throat

Syncope

100%

80%

60%

40%

20%

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

0 / 12Eligibility criteria met

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.