Niraparib + Optune for Glioblastoma
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What makes the treatment Niraparib + Optune unique for glioblastoma?
What is the purpose of this trial?
This trial tests niraparib and TTFields in patients with recurrent glioblastoma. The electric fields weaken the cancer cells, and the drug stops them from fixing themselves, leading to cell death. Tumor-Treating Fields (TTFields) is a noninvasive cancer treatment that uses low-intensity alternating electric fields to disrupt cell division and has been FDA-approved for glioblastoma.
Eligibility Criteria
This trial is for adults over 22 with recurrent glioblastoma after radiation therapy. They must understand and consent to the study, have measurable disease by MRI, be in stable health with a life expectancy over 3 months, and agree to contraception. Excluded are those with certain blood disorders, prior Optune use within 6 months, hypersensitivity to treatment components or severe medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants in Cohort A initiate TTFields therapy for 5-7 days prior to starting niraparib. Participants in Cohort B receive TTFields for 5-7 days prior to planned surgical resection, undergo surgical resection, resume TTFields postoperatively, and initiate niraparib 5-7 days after starting TTFields postoperatively.
Treatment Continuation
Participants continue with niraparib and TTFields therapy. Monitoring for disease control and adverse events.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments for disease control and survival outcomes.
Treatment Details
Interventions
- Niraparib
- Optune
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 Pennsylvania
Lead Sponsor
Tesaro, Inc.
Industry Sponsor
NovoCure Ltd.
Industry Sponsor
Ashley Cordova
NovoCure Ltd.
Chief Executive Officer
Bachelor of Science in Material Engineering from Ben-Gurion University of the Negev, Israel
Uri Weinberg
NovoCure Ltd.
Chief Medical Officer since 2020
MD from an unspecified institution