26 Participants Needed

Niraparib + Panitumumab for Colorectal Cancer

(NIPAVect Trial)

Recruiting at 2 trial locations
OA
Overseen ByOlatunji Alese, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

Panitumumab, when used with other treatments for colorectal cancer, has been associated with serious side effects like skin rash, diarrhea, and low magnesium levels, and in some cases, increased risk of death. It is important to discuss potential risks with your doctor.12356

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

OA

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

I've had chemotherapy before and either it didn't work, I couldn't tolerate it, or I'm currently on a stable first line treatment.
I am fully active and can carry on all pre-disease activities without restriction.
I agree to use birth control from the start of the study until 6 months after it ends.
See 11 more

Exclusion Criteria

I do not have active brain or spinal cord cancer symptoms.
Participant must not be simultaneously enrolled in any interventional clinical trial
I haven't had significant radiation therapy affecting my bone marrow recently.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive niraparib orally once daily and panitumumab intravenously on days 1 and 15, with cycles repeating every 28 days

28 days per cycle
2 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 5 years
1 visit at 30 days, then every 6 months for 2 years, and annually thereafter

Treatment Details

Interventions

  • Niraparib
  • Panitumumab
Trial OverviewThe trial is testing the combination of niraparib (an enzyme inhibitor) and panitumumab (a monoclonal antibody immunotherapy) on patients with RAS wildtype colorectal cancer. The goal is to see if this drug duo can better halt tumor growth compared to current treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (niraparib, panitumumab)Experimental Treatment2 Interventions
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.

Niraparib is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Zejula for:
  • 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
🇺🇸
Approved in United States as Zejula for:
  • 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
🇨🇦
Approved in Canada as Zejula for:
  • 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

GlaxoSmithKline

Industry Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

A clinical trial showed that adding panitumumab to bevacizumab and chemotherapy for first-line treatment of metastatic colorectal cancer resulted in worse progression-free survival and increased toxicity compared to bevacizumab and chemotherapy alone.
Patients receiving panitumumab experienced a higher incidence of severe adverse events (87% vs. 72%) and a greater risk of death (9% vs. 4%), leading to the conclusion that panitumumab should not be recommended in this treatment setting.
FDA review of a panitumumab (Vectibix) clinical trial for first-line treatment of metastatic colorectal cancer.Giusti, RM., Cohen, MH., Keegan, P., et al.[2018]
Panitumumab (Vectibix) was evaluated in a trial with 463 patients suffering from advanced colorectal cancer, showing a mean progression-free survival (PFS) of 96 days compared to 60 days for those receiving only best supportive care, indicating a significant benefit in delaying disease progression.
Despite the improvement in PFS and an objective response rate of 8%, there was no difference in overall survival between the treatment groups, leading to accelerated approval by the FDA with the requirement for further confirmation of clinical benefit for full approval.
U.S. Food and Drug Administration approval: panitumumab for epidermal growth factor receptor-expressing metastatic colorectal carcinoma with progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.Giusti, RM., Shastri, K., Pilaro, AM., et al.[2020]
Panitumumab (Vectibix) is approved for treating metastatic colorectal cancer specifically in patients with EGFR-expressing tumors that have non-mutated K-ras genes after standard chemotherapy has failed.
In a phase III study, patients receiving panitumumab along with best supportive care experienced significantly longer progression-free survival compared to those who only received best supportive care.
[Panitumumab].Musch, A.[2018]

References

FDA review of a panitumumab (Vectibix) clinical trial for first-line treatment of metastatic colorectal cancer. [2018]
U.S. Food and Drug Administration approval: panitumumab for epidermal growth factor receptor-expressing metastatic colorectal carcinoma with progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. [2020]
[Panitumumab]. [2018]
Vemurafenib and panitumumab combination tailored therapy in BRAF-mutated metastatic colorectal cancer: a case report. [2021]
FDA drug approval summary: panitumumab (Vectibix). [2018]
Panitumumab monotherapy in patients with previously treated metastatic colorectal cancer. [2018]
Spotlight on panitumumab in metastatic colorectal cancer. [2018]
Panitumumab: a review of its use in metastatic colorectal cancer. [2021]