Niraparib vs Temozolomide for Brain Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should have stable or decreased doses of dexamethasone, not exceeding 5 mg daily, within 7 days before randomization.
What data supports the effectiveness of the drug Niraparib for brain cancer?
Niraparib has been shown to be effective in treating brain metastases in patients with ovarian and endometrial cancer, as it can enter the brain and suppress tumor growth. In one case, a patient with brain metastases from endometrial cancer remained free of disease progression for 6 months after treatment with Niraparib.12345
Is there safety data available for Temozolomide in humans?
Temozolomide has been studied in humans, particularly for brain cancer, and is generally considered safe when used in combination with other treatments like radiotherapy. It has been shown to reduce the odds of death in patients with glioblastoma, a type of brain cancer, indicating its safety and effectiveness in this context.678910
How does the drug Niraparib differ from Temozolomide for brain cancer?
Niraparib is a PARP inhibitor, which works by preventing cancer cells from repairing their DNA, while Temozolomide is a chemotherapy drug that can cross the blood-brain barrier to treat brain tumors. Niraparib's unique mechanism of action may offer a novel approach compared to the traditional chemotherapy method of Temozolomide.811121314
What is the purpose of this trial?
The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are:Does niraparib improve progression-free survival (PFS) compared to TMZ?Does niraparib improve overall survival (OS) compared to TMZ?Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ.* study drug (Niraparib) or* comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma).The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks.Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study.Participants' tasks will include:* Complete study visits as scheduled* Complete a diary to record study medication
Research Team
Nader Sanai, MD
Principal Investigator
Ivy Brain Tumor Center
Eligibility Criteria
This trial is for adults over 18 with a new diagnosis of glioblastoma multiforme (GBM) that hasn't been treated yet, except for surgery. Participants need to be in good physical condition and not planning pregnancy or breastfeeding. They must agree to use effective contraception.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily study medication (Niraparib or Temozolomide) while undergoing standard of care radiation therapy for 6-7 weeks
Adjuvant Treatment
Participants may continue to take Niraparib or Temozolomide as long as the cancer does not progress or until completion of 6 cycles of treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Niraparib
- Temozolomide
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?
Ivy Brain Tumor Center
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