- The Gliofocus Study is now open in Paris and Madrid. The global Gliofocus network includes 68 EU medical centers.
- In the United States, The NeuroMedical Center Clinic and UC San Diego Moores Cancer Center have been added as study sites, with additional site activations anticipated nationally and internationally within the next month.
- Gliofocus is a global, registrational, randomized, controlled Phase 3 clinical trial comparing niraparib vs temozolomide in newly diagnosed MGMT-unmethylated glioblastoma patients.
- Final results of the Gliofocus Study are intended to be provided to regulatory authorities to support the assessment of niraparib as a potential treatment for newly diagnosed MGMT-unmethylated glioblastoma.
The Ivy Brain Tumor Center at Barrow Neurological Institute has announced the expansion of the Gliofocus Study, activating two new sites in Europe and two additional locations in the United States. The newly activated sites include Groupe Hospitalier Pitié-Salpêtrière in Paris, France; Hospital Universitario 12 de Octubre in Madrid, Spain; The NeuroMedical Center Clinic in Baton Rouge, Louisiana; and UC San Diego Moores Cancer Center in La Jolla, California. The Gliofocus Study is an open-label, randomized Phase 3 trial (NCT06388733) that will compare the efficacy of niraparib, a PARP1/2 selective inhibitor, to temozolomide head-to-head in adult patients with newly diagnosed MGMT-unmethylated glioblastoma.
This trial, supported by GSK, aims to enroll 450 participants across more than 100 clinical sites in 13 countries. Along with the three newly activated U.S. sites, additional locations in Texas, Minnesota, Maine, and Vermont are expected to open in Q1.
“The Gliofocus Study provides an opportunity for patients to access cutting-edge research that has the potential to change glioblastoma treatment in the future,” says David Piccioni, MD, PhD, the study investigator and leader of the Brain Tumor Program at UC San Diego Moores Cancer Center. “Our teams are dedicated to bringing the latest scientific advancements to our community and providing new treatment options to patients and families.”
“Patients with MGMT-unmethylated glioblastoma have little benefit from chemotherapy such as temozolomide, and there is an urgent need to find new drugs that improve the efficacy of radiotherapy. PARP inhibition has a strong rationale, and niraparib is a safe drug that can be easily combined with radiotherapy in brain tumours,” says Dr. Juan M. Sepúlveda, the study investigator at Hospital Universitario 12 de Octubre.
“I look forward to more and better glioblastoma treatment options. Collaborating on clinical trials like this offers hope for an improved future to patients and their families and a better scientific understanding of how to best fight this aggressive brain tumor,” says Dr. Jon D. Olson, the study investigator at The NeuroMedical Center Clinic.
An estimated 250,000 people are diagnosed with glioblastoma, one of the deadliest human cancers, each year worldwide.1 In approximately 60% of glioblastoma tumors, the MGMT promoter is unmethylated,2 and for this population, the standard of care first-line chemotherapy, temozolomide, has limited effect. The historical median overall survival for patients in this category is just 12.7 months.3,4 Positive interim data from the Ivy Center’s Phase 0/2 clinical trial of niraparib in patients with this tumor type prompted its acceleration to the Phase 3 setting. In the ongoing early-phase trial, niraparib achieved pharmacologically relevant concentrations in excess of any other PARP inhibitor in glioblastoma tumor tissue and led to a median overall survival of 20.3 months, while historically the similar population treated with standard of care has a median overall survival of 14 months.3,4 Safety was consistent with the known safety profile of niraparib, and no new concerns were identified.
“We are excited to welcome Dr. Sepúlveda, Dr. Touat, Dr. Olson, Dr. Piccioni, and many other esteemed investigators to the Gliofocus Study,” says Dr. Nader Sanai, director of the Ivy Brain Tumor Center and study chair. “Each new site activation represents a meaningful step forward in improving outcomes for MGMT-unmethylated glioblastoma patients. This pivotal trial can potentially redefine what is possible in brain cancer treatment.”
Patients and care partners can learn more about enrollment by visiting Gliofocus.org and NCT06388733.
The Ivy Center is home to the largest Phase 0 drug development program for brain cancer worldwide. Click here for a complete list of Ivy Center clinical trials.
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About Niraparib
The drug, niraparib, is an oral, once-daily PARP inhibitor with current indications in first-line maintenance for advanced ovarian cancer. GSK continues to assess the potential for niraparib in several pivotal trials across multiple tumor types and in combination with other therapeutics.
About Ivy Brain Tumor Center
Ivy Brain Tumor Center at Barrow Neurological Institute in Phoenix, AZ, is a tertiary care and nonprofit translational research program that employs bold, early-phase clinical trial strategies to identify new treatments for aggressive brain tumors, including glioblastoma. Our leading experts in neurosurgical oncology, neuro-oncology, radiation oncology, neuroradiology, neuropathology and neuroscience nursing treat more patients annually than any other brain tumor center in the United States. The Ivy Center’s Phase 0 clinical trials program is the largest in the world and enables personalized care in a fraction of the time and cost associated with traditional drug development. In addition, unlike conventional clinical trials focusing on single drugs, the Ivy Center’s accelerated program tests therapeutic combinations matched to individual patients. We leave no stone unturned in the pursuit of hope and healing. Learn more at IvyBrainTumorCenter.org. Follow the Ivy Brain Tumor Center on Facebook, Instagram, Twitter, and LinkedIn.
- Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries
- Taylor JW, Schiff D. Treatment considerations for MGMT-unmethylated glioblastoma. Curr Neurol Neurosci Rep. 2015;15(1):507.
- Hegi ME, Diserens AC, Gorlia T, et al. MGMT gene silencing and benefit from temozolomide in glioblastoma.
- Annavarapu S, Gogate A, Pham T, et al. Treatment patterns and outcomes for patients with newly-diagnosed glioblastoma multiforme: a retrospective cohort study. CNS Oncol. 2021;10(3):CNS76.
- David Piccioni, MD, PhD
- Jon D. Olson, MD