Niraparib for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Niraparib, a new treatment option for individuals with advanced pancreatic cancer. The goal is to determine if Niraparib can manage this cancer type when standard treatments prove ineffective. The trial seeks participants with specific genetic mutations, such as changes in BRCA1 or BRCA2 genes, who have already tried at least one other treatment. Those who have not responded well to treatments like FOLFOX or FOLFIRINOX may not qualify. Participants must have a measurable form of cancer that can be tracked during the study. As a Phase 2 trial, this research measures how well Niraparib works in an initial, smaller group, offering a chance to contribute to significant advancements in cancer treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on certain therapies like cytotoxic chemotherapy, radiotherapy, or investigational therapies, you may need to stop them at least 2 weeks before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that Niraparib is likely to be safe for humans?
Research has shown that niraparib has been tested for safety in cancer patients and generally has a manageable safety profile. The main safety concern is myelosuppression, a decrease in blood cells, which can cause fatigue and increase infection risk.
The FDA has approved niraparib for some cancer types, indicating it has passed safety checks for those uses. While this does not guarantee safety for pancreatic cancer, it is a positive sign. Overall, the drug appears promising but carries risks that participants should consider.12345Why do researchers think this study treatment might be promising for pancreatic cancer?
Unlike the standard treatments for pancreatic cancer, which often involve chemotherapy and radiation, niraparib is a targeted therapy that works by inhibiting a protein called PARP. This protein plays a crucial role in repairing DNA damage in cancer cells, so blocking it can lead to cancer cell death, potentially slowing the progression of the disease. Researchers are excited about niraparib because it offers a more precise approach, potentially leading to fewer side effects and better outcomes compared to traditional treatments. Additionally, niraparib is administered orally, making it a more convenient option for patients.
What evidence suggests that Niraparib might be an effective treatment for pancreatic cancer?
Research has shown that niraparib, which participants in this trial will receive, may help treat pancreatic cancer. Studies have found that this drug can assist patients with advanced pancreatic cancer by extending the time before the disease worsens. One study noted that niraparib offered a significant benefit, with many patients experiencing no cancer progression for at least six months. These results suggest that niraparib could be a helpful option for those facing this challenging disease.46789
Who Is on the Research Team?
James M. Cleary
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults with advanced pancreatic cancer who've had at least one prior treatment. They must have measurable disease, be in good physical condition (ECOG 0 or 1), and have proper organ function. Women of childbearing potential must test negative for pregnancy and agree to contraception; men also need to commit to using birth control. Participants can't join if they've recently received certain therapies, have specific blood disorders, are immunocompromised, or have untreated brain metastases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive niraparib orally once daily
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Niraparib
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Tesaro, Inc.
Industry Sponsor