450 Participants Needed

Niraparib vs Temozolomide for Brain Cancer

Recruiting at 23 trial locations
SN
Overseen ByStudy Navigator
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ivy Brain Tumor Center
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

NS

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

My diagnosis is a new brain tumor identified as GBM.
I am considered suitable for a specific radiation therapy plan.
I have enough tissue samples for further testing, or I might get approval for less.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily study medication (Niraparib or Temozolomide) while undergoing standard of care radiation therapy for 6-7 weeks

6-7 weeks
Weekly visits during radiation therapy

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

Up to 6 cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Every 16 weeks on days of MRI

Treatment Details

Interventions

  • Niraparib
  • Temozolomide
Trial Overview The study compares the effectiveness of niraparib against temozolomide (TMZ), which is standard treatment for GBM without MGMT methylation. It will assess if niraparib can extend the time before cancer worsens or improve overall survival compared to TMZ.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: NiraparibExperimental Treatment1 Intervention
Group II: Arm B: TemozolomideActive Control1 Intervention

Niraparib is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Zejula for:
  • 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
🇺🇸
Approved in United States as Zejula for:
  • 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
🇨🇦
Approved in Canada as Zejula for:
  • 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

Trials
12
Recruited
910+

GlaxoSmithKline

Industry Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Findings from Research

Niraparib, a PARP inhibitor, was successfully used to treat a 62-year-old woman with endometrial cancer and brain metastases, leading to 6 months of disease-free progression, highlighting its potential efficacy in this rare condition.
The drug's ability to cross the blood-brain barrier allows for higher concentrations in brain tissues, which may enhance its tumor-suppressing effects, suggesting a promising mechanism of action for treating brain metastases from endometrial cancer.
Successful treatment of a patient with brain metastases from endometrial cancer using Niraparib: a case report.Wang, Q., Zhang, F., Gao, H., et al.[2021]
Niraparib, a recently approved treatment for recurrent platinum-sensitive ovarian cancer, has demonstrated a high oral bioavailability of 72.7% in humans, indicating effective absorption when taken orally.
The study involved six patients who received a therapeutic dose of 300 mg of niraparib, followed by a small intravenous dose to measure its levels in the bloodstream, confirming its potential as a convenient oral treatment option.
Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients.van Andel, L., Rosing, H., Zhang, Z., et al.[2019]
Niraparib, a PARP inhibitor, is recommended as a maintenance treatment for patients with platinum-sensitive relapsed ovarian cancer, leveraging the concept of synthetic lethality in BRCA mutation carriers.
A case study of a 68-year-old woman with brain metastases from high-grade serous ovarian cancer showed that she remained free of disease progression for over 17 months while on niraparib after second-line chemotherapy.
Niraparib as maintenance therapy in a patient with ovarian cancer and brain metastases.Gray, S., Khor, XY., Yiannakis, D.[2021]

References

Successful treatment of a patient with brain metastases from endometrial cancer using Niraparib: a case report. [2021]
Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients. [2019]
Niraparib as maintenance therapy in a patient with ovarian cancer and brain metastases. [2021]
Niraparib: A Review in First-Line Maintenance Therapy in Advanced Ovarian Cancer. [2022]
Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer. [2021]
Safety of bevacizumab in patients with non-small-cell lung cancer and brain metastases. [2022]
NRG/RTOG 0837: Randomized, phase II, double-blind, placebo-controlled trial of chemoradiation with or without cediranib in newly diagnosed glioblastoma. [2023]
Microdialysis measurement of intratumoral temozolomide concentration after cediranib, a pan-VEGF receptor tyrosine kinase inhibitor, in a U87 glioma model. [2021]
Odds of death after glioblastoma diagnosis in the United States by chemotherapeutic era. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of Temozolomide and Radiotherapy on Brain Metastatic Tumor: A Systematic Review and Meta-Analysis. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Temozolomide for treating brain metastases. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
A phase 2 study of radiosurgery and temozolomide for patients with 1 to 4 brain metastases. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Profound prevention of experimental brain metastases of breast cancer by temozolomide in an MGMT-dependent manner. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Cediranib enhances control of wild type EGFR and EGFRvIII-expressing gliomas through potentiating temozolomide, but not through radiosensitization: implications for the clinic. [2021]
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