Clinical Trials Roundup – New Study Currently Enrolling: March 2018

Clinical trials help bring much needed treatments and therapies to market. Pacific Neuroscience Institute is pleased to announce that it has opened a new study for traumatic brain injury patients who have been suffering from chronic motor deficits for more than a year. This study is currently enrolling patients.

 

New Study

SanBio, Inc. (PDF): Study of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Traumatic Brain Injury (NCT02416492). This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from traumatic brain injury.

 

Actively Recruiting Studies

BRAIN CANCER (Primary)

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)

Boston Biomedical (PDF): A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients WithRecurrent or Progressive Glioblastoma (GBM) Following Initial Therapy (NCT03149003)

Caris (PDF): Caris Molecular Intelligence Repository

Medicenna Therapeutics, Inc. (PDF): An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma (NCT02858895)

Nativis 101 (PDF): A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM) (NCT02296580)

Nativis 109 (PDF): A Feasibility Study of the Nativis Voyager System in Patients With Newly-Diagnosed Glioblastoma Multiforme (GBM) (NCT03276268)

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/Saint John’s Cancer Institute (PDF): Neurological Outcomes in Health and Disease

Triphase MRZ-112 (PDF): Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer (NCT02903069)

 

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)

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)

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

 

SOLID TUMORS

Caris (PDF): Caris Molecular Intelligence Repository

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

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)

 

Completed/Recently Closed Studies

NEUROLOGY

SanBio, Inc. / Sunovion: 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.

 

NEURO-ONCOLOGY

AbbVie / RTOG: A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification

CancerLife: Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study

EpiCentRX: Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases (BRAINSTORM) 

ImmunoCellular: 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

Inspyr Therapeutics: Efficacy, Safety and CNS Exposure of G-202 in Patients with PSMA-Positive Recurrent or Progressive Glioblastoma

Kadmon: 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

Triphase MRZ-108: Phase 2 Trial of Single Agent Marizomib in Progressive or Recurrent Grade IV Malignant Glioma

Investigators:
Achal S. Achrol, MD
Garni Barkhoudarian, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Steven O’Day, MD
Marlon Garzo Saria, PhD, RN, AOCNS, FAAN

 

Clinical Trials Team:
Najee Boucher, CRA
Jaya M. Gill, RN, BSN
Annie Heng, RN, BSN
Tiffany Juarez, PhD
Anand Moses, CRA

 

For more information, please click the links or contact the Clinical Trials Team at: 
e-mail: neuro.oncology@jwci.org  |  phone: 310-829-8265