Niraparib for Metastatic Pancreatic Cancer
(NIRA-PANC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Niraparib, a drug typically used for ovarian cancer, can help control metastatic pancreatic cancer. Researchers are also assessing the safety of Niraparib for this purpose. Participants will take the drug daily in 28-day cycles. This trial may suit individuals with confirmed pancreatic cancer that has spread and who have either undergone prior chemotherapy or cannot tolerate it. Participants must have specific genetic mutations in their tumor tissue and be able to swallow pills. As a Phase 2 trial, this research measures Niraparib's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that Niraparib is likely to be safe for humans?
Research has shown that Niraparib is well-tolerated by patients with advanced solid tumors. In one study, patients took Niraparib at doses of 200 or 300 mg per day, and the results indicated that the medication was generally safe and worked predictably in the body.
The FDA has already approved Niraparib for treating ovarian cancer, establishing a known safety record for that condition. However, its use in pancreatic cancer remains under investigation. While this does not guarantee safety for pancreatic cancer patients, it offers some reassurance about its overall safety in humans.
As with any treatment, side effects may occur. Existing data suggest that many patients can tolerate Niraparib at the studied doses. It is important to consult a healthcare provider about potential risks and benefits before joining a trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard chemotherapy and targeted therapies for metastatic pancreatic cancer, Niraparib is a PARP inhibitor, which targets the DNA repair process in cancer cells. This mechanism of action is different because it exploits the cancer cells' inability to repair their DNA, potentially leading to their death. Researchers are excited about Niraparib because it offers a targeted approach, which might result in better outcomes with potentially fewer side effects compared to conventional treatments. Additionally, its oral administration is more convenient than many current intravenous options.
What evidence suggests that Niraparib might be an effective treatment for metastatic pancreatic cancer?
Research has shown that Niraparib, which participants in this trial will receive, is a promising treatment for advanced pancreatic cancer. In one study, 44% of patients who took Niraparib did not experience cancer progression for at least six months, indicating stable cancer in nearly half of the patients during that period. Niraparib blocks certain enzymes that help cancer cells repair themselves, making it harder for the cancer to grow. Already approved for treating ovarian cancer, it has proven its ability to fight cancer cells. Early results suggest it could offer similar benefits for pancreatic cancer patients.34678
Who Is on the Research Team?
Anup Kasi, MD
Principal Investigator
The University of Kansas Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with metastatic pancreatic cancer who've had prior chemotherapy. They must have specific gene mutations related to DNA repair, be able to take oral medication, and have adequate organ function. Participants need effective birth control if applicable and can't join if they're pregnant or breastfeeding, have certain blood disorders like MDS/AML, are on other clinical trials or investigational drugs within the last 4 weeks, or have severe psychiatric issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Niraparib 300 mg daily for 28 days per cycle, with dose adjustments based on weight and platelet count
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
University of Kansas Medical Center
Lead Sponsor
Tesaro, Inc.
Industry Sponsor