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November Clinical Trials at PNI
November 2, 2020

Clinical Trials Round-Up: November 2020

by Mini Gill

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)

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)

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


Solid tumor icon illustration

Solid Tumors


Bayer (PDF): ON-TRK: PrOspective Non-interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer treated with Larotrectinib (NCT03025360)

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


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


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

Neurametrix (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

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


Upcoming Trials


Brain Metastases – Blue Earth Diagnostics FLC 219: An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 2b Study to Establish Image Interpretation Criteria for 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy (PURSUE)

Newly Diagnosed GBM – Trident EF-32: A Phase III Randomized, open-label study of Optune® (TTFields, 200KHZ) concomitant with radiation therapy and temozolomide for the treatment of newly diagnosed glioblastoma

Newly Diagnosed GBM – Theradex OKN-007: Phase II trial investigating the efficacy, safety, and pharmacokinetic properties of OKN-007 combined with TMZ in recurrent Glioblastoma multiforme patients (1st relapse) 

Solid Tumor – Spectrum 107: An Open-label, Nonrandomized, Phase 1 Drug-Drug Interaction Study to Evaluate the Pharmacokinetics of Belinostat in Combination with Atazanavir in Patients with Advanced Relapsed/Refractory Solid Tumors or Hematological Malignancies 


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:

Garni Barkhoudarian, MD
Jose Carrillo, MD
Chester Griffiths, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Jean-Philippe Langevin, MD
Sarah McEwen, PhD, NSCA-CPT 
David Merrill, MD  
Melita Petrossian, MD
Marlon Garzo Saria, PhD, RN, FAAN
Naveed Wagle, MD

Clinical Trials Team:

Ashley Archer, CRA
ArcherA@jwci.org
310-582-7460
Delisa Madere, RA 
Delisa.Madere@providence.org
Aarthi Ganapathi, CRA 
Aarthi.Ganapathi@providence.org
424-216-8269
Raffi Nersesian, CRA 
Raffi.Nersesian@providence.org
310-829-8808
Annie Heng, RN, BSN
Annie.Heng@providence.org
310-582-7457
Hanh Nguyen, CRA 
NguyenThuyH@jwci.org
310-582-7434
Audrey Hiemer, RN 
Audrey.Hiemer@providence.org
310-582-7097
Brittany Youssef, CRA 
Brittany.Youssef@providence.org
Jack Hodes, CRA 
jhodes@pacificneuro.org
Gacia Tachejian, CRA 
Gacia.Tachejian@providence.org

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: November 17th, 2020