Clinical Trials Round-Up: December 2020

New Studies

Blue Earth Diagnostics FLC-219: (PDF): 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) (NCT04410367)

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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)

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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Solid Tumors

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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) 

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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) 

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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) 

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 

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Upcoming Trials

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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 Akanksha Sharma, MD Naveed Wagle, MD

Clinical Trials Team:

Ashley Archer, CRA ArcherA@jwci.org 310-582-7460	Raffi Nersesian, CRA  Raffi.Nersesian@providence.org 310-829-8808
Aarthi Ganapathi, CRA  Aarthi.Ganapathi@providence.org 424-216-8269	Hanh Nguyen, CRA  NguyenThuyH@jwci.org 310-582-7434
Annie Heng, RN, BSN Annie.Heng@providence.org 310-582-7457	Brittany Youssef, CRA  Brittany.Youssef@providence.org 310-582-7611
Jack Hodes, CRA  jhodes@pacificneuro.org 310-156-5933	Gacia Tachejian, CRA  Gacia.Tachejian@providence.org 310-582-7611
DeLisa Madere, RA  Delisa.Madere@providence.org 310-449-5271