Clinical Trials Roundup: June 2017

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

Stroke

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

AbbVie / RTOG (PDF): A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification (NCT02646748)

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)

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)

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

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)

Triphase MRZ-108 (PDF): Phase 2 Trial of Single Agent Marizomib in Progressive or Recurrent Grade IV Malignant Glioma (NCT02330562)

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)

EpiCentRX (PDF): Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases (BRAINSTORM) (NCT02215512)

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)

 

Solid Tumors

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

CancerLife (PDF): Evaluation of a Mobile Digital Solution for Cancer Care and Research: A Feasibility Study (NCT03094741)

 

For more information, please click the hyperlinks or contact the Neuro-Oncology Clinical Trial Team at: neuro.oncology@jwci.org  |  310-829-8265  |  clinical trials website

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
Marlon Garzo Saria, PhD, RN, AOCNS, FAAN