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Clinical Trials Round Up July 2020
August 4, 2020

Neuroscience Clinical Trials Round-Up: July 2020

by Mini Gill

New Studies


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 )


Actively Recruiting Studies


Brain Cancer (Primary) – Glioma


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 )


Non-Glioma


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 )


Solid tumor icon illustration

Solid Tumors


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 ) 


Neurology


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 


Quality and Outcomes Research


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:

Jack Hodes, CRA 
jhodes@pacificneuro.org

Raffi Nersesian, CRA Raffi.Nersesian@providence.org
310-829-8808

Hanh Nguyen, CRA 
NguyenThuyH@jwci.org
310-582-7434

About the Author

Jaya Mini Gill, RN, BSN

Mini Gill

Jaya Mini Gill, RN, BSN is involved in all aspects of clinical trial study design and processes in the Department of Translational Neurosciences and Neurotherapeutics at the John Wayne Cancer Institute. An experienced nurse, she is responsible for accurate protocol implementation along with the treatment, care, management, and follow-up of patients.

Last updated: September 16th, 2020