Clinical Trials Round Up: January 2020

Pacific Neuroscience Institute has a strong roster of clinical trials for a number of neurological conditions including brain tumor, Cushing’s disease and Lewy bodies dementia. Find out what is in store for 2020.

—————————- Last 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: (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 (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)

PNI/JWCI (Neoadjuvant/PIN)  (PDF): A Longitudinal Assessment of Tumor Evolution in Patients with Brain Cancer  (NCT03425292)

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

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)

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)

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)

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 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