Niraparib for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests how well the drug niraparib treats brain cancer that has spread to the central nervous system (CNS). Taken once daily, niraparib aims to prevent cancer from worsening. This trial may suit individuals with solid tumor cancer that has spread to the brain, particularly if they have minimal symptoms and specific genetic changes related to cancer. Participants should not have received prior treatment with certain drugs like PARP inhibitors and must be able to swallow capsules. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you can continue taking letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab, bisphosphonates, denosumab, or ovarian suppression therapy. If you are on other medications, it's best to discuss 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 studied for safety. Some studies found it can cause serious side effects, such as bone marrow issues and a type of blood cancer, though these risks are not common for everyone. Another study found that niraparib might be absorbed by brain tumors better than some other drugs, potentially making it more effective for treating brain cancer.
As this trial is in an early stage, researchers are still gathering safety information. While some side effects are known, more data is needed to fully understand how well people can tolerate niraparib over time.12345Why do researchers think this study treatment might be promising?
Niraparib is unique because it targets the DNA repair mechanism in brain cancer cells. Unlike standard treatments like chemotherapy and radiation, which broadly attack rapidly dividing cells, niraparib specifically inhibits the PARP enzyme. This inhibition prevents cancer cells from repairing their DNA, leading to cell death. Researchers are excited about niraparib because its targeted approach could offer a more effective and less toxic treatment option for brain cancer patients.
What evidence suggests that niraparib might be an effective treatment for brain cancer?
Research has shown that niraparib, the treatment under study in this trial, can effectively reach brain tumors and alter their growth. Studies have found that it crosses the blood-brain barrier well, which is crucial for treating cancer that has spread to the brain. In patients with newly diagnosed brain tumors, niraparib has provided an average of 11.7 months without cancer worsening. Early research also suggests it may extend survival when combined with radiotherapy for glioblastoma, a type of brain cancer. These findings support niraparib's potential in treating cancers that have spread to the central nervous system.14567
Who Is on the Research Team?
Priscilla K. Brastianos
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults with solid tumors that have spread to the brain and are minimally symptomatic. Participants must have measurable CNS disease, be stable on medications, and not have had recent major surgery or blood transfusions. They should not have been treated with PARP inhibitors before and must not be pregnant or breastfeeding. A good performance status and normal organ function are required.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive niraparib 1x daily for each 28-day cycle up to 2 years or until disease worsens or unacceptable side effects occur
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?
Massachusetts General Hospital
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