Clinical Trials Roundup: June 2017
by Marlon Saria
We are pleased to add a non-cancer Ischemic Stroke study to our roster of clinical trials at Pacific Neuroscience Institute. In addition we have several ongoing trials in glioblastoma multiforme (GBM) and quality & outcomes research as well as brain cancer. Please contact our centers for eligibility criteria.
Newly Opened Clinical Trial
SanBio, Inc. / Sunovion (PDF): A Double-Blind, Controlled Phase 2b Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (NCT02448641).
This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke. The study will be conducted at approximately 65 sites in the United States.
SB623 cells are bone-marrow-derived stromal cells that have been transiently transfected with the intercellular domain of the human Notch-1 gene.
If you are interested to learn more about this trial, click the pdf flyer link above or contact Principal Investigator, Dr. Achal S. Achrol.
Actively Recruiting Studies
Primary Brain Cancer
ImmunoCellular (PDF): A Phase III Randomized Double-Blind, Controlled Study of ICT-107 with Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma following Resection and Concomitant TMZ Chemoradiotherapy (NCT02546102)
Medicenna Therapeutics, Inc. (PDF): An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Glioblastoma at First Recurrence or Progression (NCT02858895)
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)
Eli Lilly and Company (PDF): A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma (NCT02308020)
Kadmon (PDF): Study of Tesevatinib in Subjects With Non-Small Cell Lung Cancer, EGFR Activating Mutation, Prior Treatment With a Tyrosine Kinase Inhibitor, and Brain Metastases or Leptomeningeal Metastases (NCT02616393)
Incyte Corporation: A Platform Study Exploring the Safety, Tolerability, Effect on the Tumor Microenvironment, and Efficacy of Pembrolizumab + INCB Combinations in Advanced Solid Tumors (NCT02646748)
Quality and Outcomes Research
About the Author
Marlon Garzo Saria, PhD, RN, AOCNS, FAAN, is an oncology clinical nurse specialist and nurse scientist for the Inpatient Oncology and Caritas concierge suites at Providence Saint John’s Health Center in Santa Monica, California. He is an Assistant Professor of Neurosciences and Neurotherapeutics and Director of the Center for Quality Outcomes and Research at Pacific Neuroscience Institute and John Wayne Cancer Institute. Dr. Saria serves in the Nurse Corps of the U.S. Air Force Reserve as a flight commander in the Aerospace Medical Squadron. He was inducted as a Fellow of the American Academy of Nursing in 2014.
Last updated: September 9th, 2019