Niraparib + Panitumumab for Colorectal Cancer
(NIPAVect Trial)
Trial Summary
What is the purpose of this trial?
This trial studies how well niraparib and panitumumab work together in treating patients with advanced colorectal cancer who have already received treatment. Niraparib blocks enzymes needed for cancer growth, while panitumumab helps the immune system attack cancer cells and stops them from spreading. Panitumumab is a fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is used in the treatment of metastatic colorectal cancer, particularly in patients with wild-type KRAS tumors.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot be enrolled in another interventional clinical trial and should not have prior therapy with certain inhibitors. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Niraparib and Panitumumab for colorectal cancer?
Panitumumab has been shown to help some patients with metastatic colorectal cancer live longer without their disease getting worse, especially when their tumors have certain genetic features. However, combining panitumumab with other treatments has sometimes led to more side effects and hasn't always improved outcomes.12345
Is the combination of Niraparib and Panitumumab safe for treating colorectal cancer?
How is the drug combination of Niraparib and Panitumumab unique for treating colorectal cancer?
The combination of Niraparib and Panitumumab for colorectal cancer is unique because it pairs a PARP inhibitor (Niraparib) with an EGFR inhibitor (Panitumumab), potentially offering a novel approach by targeting different pathways involved in cancer growth, which is not a standard treatment for this condition.12378
Research Team
Olatunji Alese, MD
Principal Investigator
Emory University
Eligibility Criteria
This trial is for adults with advanced colorectal cancer that has spread, who have tried at least one systemic therapy. They must be in good physical condition (ECOG ≤ 1), have adequate blood counts and organ function, and not be pregnant or fathering a child. Those with prior treatment using PARP or EGFR inhibitors, active brain metastases, known hypersensitivity to the drugs being tested, or other serious health issues are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive niraparib orally once daily and panitumumab intravenously on days 1 and 15, with cycles repeating every 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Niraparib
- Panitumumab
Niraparib is already approved in European Union, United States, Canada for the following indications:
- Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
- Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
- Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
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Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
GlaxoSmithKline
Industry Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
National Institutes of Health (NIH)
Collaborator
National Cancer Institute (NCI)
Collaborator