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December 26, 2019

Clinical Trials Round Up: December 2019

by Mini Gill

—————————- Final Call —————————-

EIP (PDF): A Double-Blind, Placebo-Controlled 16-Week Study of the Cognitive Effects of the Oral P38 Alpha Kinase Inhibitor Neflamapimod in Dementia with Lewy Bodies (DLB) (NCT04001517)

  —————————- Actively Recruiting Studies —————————-

Brain Cancer (Primary)

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)

Aivita Biomedical (PDF): Phase II trial of AV-GBM-1 (autologous dendritic cells loaded with autologous tumor associated antigens) as an adjunctive therapy following primary surgery plus concurrent chemoradiation in patients with Newly-Diagnosed Glioblastoma Multiforme (GBM) (NCT03276268)  

Boehringer Ingelheim (PDF): A Phase I Dose Escalation and CNS Pharmacokinetic Study of the ErbB Family Inhibitor Afatinib in Patients with Recurrent or Progressive Brain Cancer (NCT02423525) 

Caris (PDF): Caris Molecular Intelligence Repository

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) 

Northwestern University: (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)

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) 

Pacific Neuroscience Institute/John Wayne Cancer Institute (PDF): Neurological Outcomes in Health and Disease

Pacific Neuroscience Institute/John Wayne Cancer Institute (PDF): A Longitudinal Assessment of Tumor Evolution in Patients with Brain Cancer (NCT03425292)

Brain Metastasis

Boehringer Ingelheim (PDF): A Phase I Dose Escalation and CNS Pharmacokinetic Study of the ErbB Family Inhibitor Afatinib in Patients with Recurrent or Progressive Brain Cancer (NCT02423525)

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)

Bioness PSSP (PDF): StimRouter™ Neuromodulation System: Implanted peripheral nerve stimulation for pain management when treating patients with chronic Post-Stroke Shoulder Pain (NCT03093935)

Chordoma (PDF): Pilot Study of Pemetrexed for the Treatment of Chordoma (NCT03955042)

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)

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)

Pacific Neuroscience Institute/John Wayne Cancer Institute (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

Pacific Neuroscience Institute/John Wayne Cancer Institute (PDF): An Observational Study of Memantine XR (extended release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN) (NCT03709888)

Pacific Neuroscience Institute/John Wayne Cancer Institute (PDF): Feasibility and Acceptability of Integrating Family Caregiver Support into Cancer Clinical

For more information, please click the hyperlinks or contact the Neurosciences Clinical Trial Team. neuro.oncology@jwci.org | neuro.trials@pacificneuro.org | 310-829-8265

Investigators:

Garni Barkhoudarian, MD, FAANS
Jose Carrillo, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Jean-Philippe Langevin, MD
Steven O’Day, MD
Melita Petrossian, MD
Marlon Garzo Saria, PhD, RN, FAAN
Naveed Wagle, MD

Clinical Trials Team:

Ashley Archer, CRA, ArcherA@jwci.org, phone 310-582-7460
Jaya Mini Gill, RN, BSN, jaya.gill@providence.org, phone 310-582-7437
Annie Heng, RN, BSN, HengA@jwci.org, phone 310-582-7457
Hanh Nguyen, CRA, NguyenThuyH@jwci.org , phone 310-582-7434
Shelly Trujillo, CRA, Shelly.Trujillo@providence.org , phone 310-582-7097

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: May 27th, 2020