Niraparib and Panitumumab in Treating Patients with Advanced or Metastatic Colorectal Cancer

Active:	Yes
Cancer Type:	Colon/Rectal Cancer Unknown Primary	NCT ID:	NCT03983993
Trial Phases:	Phase II	Protocol IDs:	Winship4517-18 (primary) NCI-2018-02757 IRB00107377
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT03983993

Summary

This phase II trial studies the side effects and how well niraparib and panitumumab work in treating patients with colorectal cancer that has spread to other places in the body. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Panitumumab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Giving niraparib and panitumumab may work better in treating patients with colorectal cancer.

Objectives

PRIMARY OBJECTIVE:
I. Evaluate the activity of the combination of niraparib with epidermal growth factor receptor (EGFR) Inhibitor panitumumab in previously treated patients with RAS WT metastatic colorectal cancer.

SECONDARY OBJECTIVES:
I. Define the toxicity profile of the combination of niraparib and panitumumab. The additional patients enrolled on the expansion cohorts will help confirm the toxicity profile.
II. Evaluate the activity of the combination of niraparib and panitumumab in previously treated patients with metastatic colorectal cancer.

OUTLINE:
Patients receive niraparib orally (PO) once daily (QD) on days 1-28 and panitumumab intravenously (IV) over 60-90 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 6 months for 2 years, and then annually for up to 5 years.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.