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A Phase II Study of Niraparib in Combination with EGFR Inhibitor Panitumumab in Patients with Advanced Colorectal Cancer

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03983993
Protocol IDs
Winship4517-18 (primary)
NCI-2018-02757
IRB00107377
Study Sponsor
Emory University Hospital / Winship Cancer Institute

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. Immunotherapy with monoclonal antibodies, such as panitumumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and panitumumab may work better in treating patients with colorectal cancer.

Objectives

PRIMARY OBJECTIVES:
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.
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