Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03983993
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Given PO
  • Panitumumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Oct 15, 2019
Status verified
Dec 2025
Primary completion
May 17, 2023
Completion
Dec 1, 2026

Study Design

Enrollment
26 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (niraparib, panitumumab)
    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.

Primary Outcome Measure

Clinical Benefit Rate (CBR) [ Time Frame: 3 years and 7 months post treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-

Find similar trials in Atlanta, GA

By research site
Emory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GA

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