Study on Niraparib and Panitumumab for Advanced or Metastatic Colorectal Cancer

Sponsor: Emory University

Sponsor score: 40

ClinicalTrials ID:NCT03983993

Provider View

This clinical trial is testing the combination of two drugs, niraparib and panitumumab, to see if they can effectively treat colorectal cancer that has spread to other parts of the body. The study aims to understand how well these drugs work together and what side effects they might cause.

Patient Parameters

Program Overview

This study is exploring whether the combination of niraparib, a drug that may stop cancer cells from growing, and panitumumab, an immunotherapy that helps the immune system attack cancer, can better treat colorectal cancer that has spread. Researchers want to see if this combination can help control the cancer more effectively than previous treatments.

Description

The main goal of this study is to see how well the combination of niraparib and panitumumab works in patients with advanced colorectal cancer that has a specific genetic type (RAS wild type) and has already been treated with other therapies. Researchers will also look at the side effects of this drug combination.

Participants in the study will take niraparib by mouth every day and receive panitumumab through an IV on specific days of a 28-day cycle. This cycle will repeat as long as the cancer does not progress and the side effects are manageable.

After finishing the study treatment, participants will have follow-up visits 30 days later, then every 6 months for 2 years, and annually for up to 5 years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have advanced colorectal cancer that has spread and is of the RAS wild type genetic type.
  • Have received at least one previous treatment for colorectal cancer.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Agree not to donate blood during the study and for 90 days after the last treatment.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 180 days after the last treatment.
  • Men must agree to use effective contraception during the study and for 180 days after the last treatment.
  • Be able to provide written informed consent to participate in the study.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Have previously been treated with PARP inhibitors or EGFR inhibitors for colorectal cancer.
  • Have a history of lung diseases like interstitial pneumonitis or pulmonary fibrosis.
  • Unable to take oral medications.
  • Have had significant radiation therapy recently.
  • Have allergies to the study drugs.
  • Have serious, uncontrolled medical conditions or infections.
  • Have a known history of HIV.
  • Have been diagnosed or treated for another cancer within the last 2 years, except for certain skin or cervical cancers.
  • Have active brain or spinal cord cancer spread.

Locations

FACILITYZIPCITYSTATE
Emory University Hospital Midtown30308AtlantaGeorgia
Emory University Hospital/Winship Cancer Institute30322AtlantaGeorgia
Emory Saint Joseph's Hospital30342AtlantaGeorgia

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