Niraparib + Panitumumab for Colorectal Cancer (NIPAVect Trial)

Palo Alto (17 mi)

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.

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 am fully active and can carry on all pre-disease activities without restriction.

My diagnosis is colorectal cancer confirmed by lab tests.

My kidney function, measured by creatinine levels, is within the normal range.

Exclusion Criteria

I do not have active brain or spinal cord cancer symptoms.

I haven't had significant radiation therapy affecting my bone marrow recently.

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.

I do not have any serious health issues that are not under control.

I have had or currently have lung scarring or inflammation.

Treatment Details

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.

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 European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Zejula for:

Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy

🇺🇸 Approved in United States 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
Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

🇨🇦 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