NCT03983993

Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate the activity of the combination of niraparib with epidermal growth factor receptor (EGFR) inhibitor panitumumab in previously treated patients with rat sarcoma gene (RAS) wild type (WT) metastatic colorectal cancer. SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of niraparib and panitumumab. 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.

Conditions

• Advanced Microsatellite Stable Colorectal Carcinoma
• Metastatic Microsatellite Stable Colorectal Carcinoma
• Microsatellite Stable
• RAS Wild Type
• Stage IV Colorectal Cancer AJCC v8
• MSI-H Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Given PO
BIOLOGICAL	Panitumumab	Given IV

Timeline

• Start date: 2019-10-15
• Primary completion: 2023-05-17
• Completion: 2026-12-01
• First posted: 2019-06-12
• Last updated: 2026-01-05
• Results posted: 2025-04-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study