Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer

NCT03983993 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 4 other identifiers: IRB00107377NCI-2018-02757Winship4517-18P30CA138292
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate (CBR)

  The efficacy, as measured by clinical benefit rate (CBR), will be assessed for the total number of patients enrolled. CBR = (Complete Response + Partial Response + Stable Disease \[CR +PR + SD\] rate. Response will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 criteria using an independent review.

  3 years and 7 months post treatment

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to 5 years post treatment

• Duration of Response (DOR)

  Up to 5 years post treatment

• Progression Free Survival (PFS)

  Up to 5 years post treatment

• Overall Survival (OS)

  Up to 5 years post treatment

Study Arms (1)

Treatment (niraparib, panitumumab)

EXPERIMENTAL

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.

Drug: Niraparib; Biological: Panitumumab

Interventions

Niraparib DRUG

Given PO

Also known as: MK-4827, Zejula

Treatment (niraparib, panitumumab)

Panitumumab BIOLOGICAL

Given IV

Also known as: ABX-EGF, Vectibix

Treatment (niraparib, panitumumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment
• Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study
• Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 180 days after the last dose of study treatment
• Participant must be able to provide written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• GlaxoSmithKline: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

niraparib; Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Olatunji Alese
• Organization: Emory University

olatunji.alese@emory.edu

404-778-6639

Study Officials

• Olatunji Alese, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: October 15, 2019
• Primary Completion: May 17, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 5, 2026
• Results First Posted: April 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)