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Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

NCT03983993•Emory University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participant must have advanced, metastatic RAS wildtype colorectal cancer and must have received at least one line of systemic therapy. Both microsatellite (MSI) high and stable (MSS) patients are eligible
•Participants may have been intolerant of, progressed on, or failed at least one line of systemic chemotherapy. Patients who are currently on first line Oxaliplatin-containing chemotherapy regimen are allowed on the trial if they have remained stable or better (\[partial response\]PR or \[complete response\]CR) for at least 4 months on that line of treatment and are being considered for maintenance therapy as standard of care
•Histologic or cytologic diagnosis of colorectal cancer
•Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
•Absolute neutrophil count ≥ 1,500/µL
•Platelets ≥ 100,000/µL
•Hemoglobin ≥ 9 g/dL
•Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
•Total bilirubin ≤ 1.5 x ULN (≤ 2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
•Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
+4 more criteria

Exclusion Criteria

•Participant must not be simultaneously enrolled in any interventional clinical trial
•Prior therapy with poly ADP (adenosine diphosphate) ribose polymerase (PARP) inhibitors or with EGFR inhibitors approved for the treatment of colorectal cancer (cetuximab or panitumumab)
•Patients with a history of interstitial pneumonitis or pulmonary fibrosis, or evidence of interstitial pneumonitis or pulmonary fibrosis during screening
•Inability to take oral medications
•Participant has had radiation therapy encompassing \> 20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to day 1 of protocol therapy
•Participant must not have a known hypersensitivity to components or excipients of niraparib or panitumumab
•Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
•Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)
•Participant must not have had diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated)
•Participant must not have known active, symptomatic brain or leptomeningeal metastases.

Locations (3)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Key Dates

Start Date

October 15, 2019

Primary Completion Date

May 17, 2023

Completion Date

December 1, 2026

Last Updated

January 5, 2026

Enrollment

ACTUAL participants

Conditions

Advanced Microsatellite Stable Colorectal CarcinomaMetastatic Microsatellite Stable Colorectal CarcinomaMicrosatellite StableRAS Wild TypeStage IV Colorectal Cancer AJCC v8MSI-H Colorectal Cancer

Interventions

Niraparib

DRUG

Panitumumab

BIOLOGICAL

Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC

NCT07281716

Metastatic Microsatellite Stable Colorectal Carcinoma

View study

RECRUITINGPHASE2

Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients

NCT05771181

Colorectal CancerMicrosatellite Stable Colorectal Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC

Vitamin E Combined With Fruquintinib and Tislelizumab in Microsatellite Stabilized Metastatic Colorectal Cancer Patients

Standard Systemic Therapy Combined With High/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer

A Study Investigating the Efficacy and Safety of LBL-007 Plus Tislelizumab in Combination With Bevacizumab Plus Fluoropyrimidine Versus Bevacizumab Plus Fluoropyrimidine in Participants With Unresectable or Metastatic Colorectal Cancer

AN0025 and Pembrolizumab Combination in Advanced Solid Tumors

Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer