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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 belowSelect...
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:Select...
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
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 moreSide effects data
From 2022 Phase 2 trial • 37 Patients • NCT0320734774%
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.
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
Eligibility Criteria:
This trial includes the following eligibility 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 do not have active brain or spinal cord cancer symptoms.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.I am not pregnant and agree to avoid pregnancy during and up to 180 days after the study.I have advanced colorectal cancer with no RAS mutation and have undergone at least one systemic therapy.I haven't had significant radiation therapy affecting my bone marrow recently.I agree not to donate blood during the study or for 90 days after the last treatment.I have been diagnosed with HIV.I have previously been treated with PARP or EGFR inhibitors for cancer.I cannot take medications by mouth.I am not allergic to niraparib or panitumumab.I haven't had any cancer treatments, except for skin or treated cervical cancer, in the last 2 years.My diagnosis is colorectal cancer confirmed by lab tests.My kidney function, measured by creatinine levels, is within the normal range.I do not have any serious health issues that are not under control.I have had or currently have lung scarring or inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (niraparib, panitumumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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