Niraparib for Recurrent Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a randomized, two-arm, open-label, phase 0 trial to assess intratumoral pharmacokinetics and pharmacodynamics of niraparib in subjects with progressive IDH1 or IDH2 mutant glioma.- This research study involves an experimental treatment called Niraparib.
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 must not have received systemic anticancer therapy or certain investigational agents within 28 days before starting the study drug. It's best to discuss your current medications with the study team.
What safety data exists for Niraparib in humans?
Niraparib, also known as Zejula, has been studied for safety in patients with ovarian cancer. Common side effects include blood-related issues like low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia), as well as digestive problems. These side effects often lead to changes in dosage or temporary pauses in treatment.12345
How is the drug Niraparib unique for treating recurrent brain cancer?
Who Is on the Research Team?
Isabel Arrillaga-Romany, MD, Ph.D
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Adults with confirmed IDH1/2 mutant glioma, evidence of tumor progression, and a Karnofsky Performance Score (KPS) ≥ 70. Must be at least 12 weeks post-CNS radiation, not pregnant or breastfeeding, agree to contraception use, have adequate organ function and no major surgery within the last 4 weeks. Cannot be on other clinical trials or have had certain treatments recently.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment - Arm A
Participants receive 1 cycle of Niraparib followed by surgery, then up to 12 cycles of Niraparib
Treatment - Arm B
Participants undergo surgery followed by up to 12 cycles of Niraparib
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Niraparib
- Resection/Treatment with Niraparib
Niraparib is already approved in European Union, United States, Canada for the following indications:
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