Neuroscience Clinical Trials Round-Up: July 2020

New Studies

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Bayer ( PDF ): ON-TRK: Pr O spective N on-interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer treated with Larotrectinib ( NCT03025360 )

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Actively Recruiting Studies

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Brain Cancer (Primary) – Glioma

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Aadi Bioscience ( PDF ): A Phase 2, Open-label Study of ABI-009 (nab-Rapamycin) in Bevacizumab-naïve Patients with Recurrent High-grade Glioma and in Patients with Newly Diagnosed Glioblastoma ( NCT03463265 )

EORTC ( PDF ): A Phase III trial of Marizomib in Combination with Standard Temozolomide-based Radiochemotherapy versus Standard Temozolomide-based Radiochemotherapy Alone in Patients with Newly Diagnosed Glioblastoma ( NCT03345095 ) 

Oncoceutics ( PDF ) Expanded Access to ONC201 for Patients with H3 K27M-mutant and/or Midline High Grade Gliomas ( NCT03134131 )

Orbus Therapeutics ( PDF ): A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy ( NCT02796261 )

PNI/JWCI : Precision Immunotherapy in Neoadjuvant Setting – A Longitudinal Assessment of Tumor Evolution in Patients with Brain Cancer ( NCT03425292 )

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Non-Glioma

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Northwestern: ( PDF ): A Phase 2, single arm, multi-center, open label trial Combining Optune with concurrent Bevacizumab in the setting of Recurrent or Progressive Meningioma ( NCT02847559 )

NovoCure, Ltd. ( PDF ): A Single-Center, Open-Label, Randomized Phase II Study of NovoTTF-200A Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas ( NCT02507232 )

Chordoma – PNI/JWCI ( PDF ): Pilot Study of Pemetrexed for the Treatment of Chordoma ( NCT03955042 )

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Incyte ( PDF ): A Phase 2, Open-Label Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants with Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations of Translocations (FIGHT-207) ( NCT03822117 )

Sanofi Aventis ( PDF ): A Phase 1/2 Open-label, Multi-center, Safety, Preliminary Efficacy and Pharmacokinetic (PK) Study of Isatuximab in Combination with Atezolizumab or Isatuximab Alone in Patients with Advanced Malignancies ( NCT03463265 )

Spectrum Pharmaceuticals ( PDF ): An Open-label, Nonrandomized, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Belinostat in Patients with Relapsed/Refractory Solid Tumors or Hematological Malignancies Who Have Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes ( NCT03276268 ) 

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Neurology

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Bioness OAB ( PDF ): Pivotal Randomized Clinical Trial of Peripheral Nerve Stimulation with StimRouter Neuromodulation System in Overactive Bladder ( NCT02873312 )

Corcept ( PDF ): Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant ( NCT03697109 ) 

Prevention ( PDF ): Precision Recommendations for Environmental Variables, Exercise, Nutrition and Training Interventions to Optimize Neurocognition in those with a underlying Mild Alzheimer’s Disease ( NCT04082611 )

Stemedica (PDF): A Phase IIA, Multi-Center, Randomized, Single-Blind, Placebo-Controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogenic Human Mesenchymal Stem Cells to Subjects with Mild to Moderate Dementia due to Alzheimer’s Disease ( NCT02833792 )

PNI/JWCI ( PDF ): Neurological Outcomes in Health and Disease 

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Quality and Outcomes Research

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CancerLife2 ( PDF ): CancerLife: Patient-Driven Solution in Cancer Care ( NCT03371147 )

Family Caregivers ( PDF ): An Exploratory Study of Caregiver Burden Among Family Caregivers of Cancer Patients ( NCT03069105 )

Neuramatrix ( PDF ): An Exploratory Study of Typing Cadence or Keystroke Dynamics as a Non-Invasive Approach to Measure Neurological Function

PNI/JWCI ( PDF ): An Observational Study of Memantine XR (extended release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN) ( NCT03709888 )

PNI/JWCI ( PDF ): Feasibility and Acceptability of Integrating Family Caregiver Support into Cancer Clinical

For more information, please contact the neurosciences Clinical Trials Team at:
E-mail: Neuro.Oncology@jwci.org or Neuro.Trials@pacificneuro.org
Phone: 310-829-8265

Investigators

Clinical Trials Team: