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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
NIPAVect Trial Summary
This trial is testing niraparib and panitumumab to see if they're effective at treating colorectal cancer.
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.Check my eligibility
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.See study design
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.
NIPAVect Trial 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.
Select...
My diagnosis is colorectal cancer confirmed by lab tests.
Select...
My kidney function, measured by creatinine levels, is within the normal range.
NIPAVect Trial 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
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 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%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Urinary tract infection
9%
Dehydration
9%
Back pain
9%
Blood bilirubin increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Hypotension
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Depression
4%
Hyponatremia
4%
Hypokalemia
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
NIPAVect 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
2020
Completed Phase 3
~6490
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,533 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,412 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,548 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.
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
Who else is applying?
What site did they apply to?
Emory University Hospital/Winship Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
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