Clinical Trials Round Up: October 2018

New Studies

Microtransponder (PDF):A Pivotal Randomized Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (VNS-REHAB) (NCT03131960)

Study is intended to provide evidence that VNS paired with rehabilitation, in subjects suffering from upper extremity paresis after stroke, is a safe and effective treatment for recovery of upper limb motor function after stroke.

 

Actively Recruiting Studies

Brain Cancer (Primary)

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)

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 With Recurrent or Progressive Glioblastoma (GBM) Following Initial Therapy (NCT03149003)

Caris (PDF): Caris Molecular Intelligence Repository

Diffusion (PDF):An Open-label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Trans Sodium Crocetinate (TSC) with Radiation Therapy and Temozolomide in Newly Diagnosed Glioblastoma (GBM) Biopsy-Only Subjects (NCT03393000)

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

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): A Longitudinal Assessment of Tumor Evolution in Patients with Brain Cancer (NCT03425292)

Prevlar (PDF): A Phase 2a Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Safety and Efficacy of Different Schedules of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinomas of the Oral Cavity or Oropharynx.(NCT03515538)

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)

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)

Pacific Neuroscience Institute/Saint John’s Cancer Institute (PDF): An Observational Study of Memantine XR (extended release) and Pregabalin Combination Therapy in Chemotherapy-Induced Peripheral Neuropathy (CIPN) (NCT03709888)

 

Not Recruiting/Recently Closed Studies

 

Neurology

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.

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.

 

Neuro-Oncology

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

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

Eli Lilly and Company: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:Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases (BRAINSTORM) (NCT02215512)

ImmunoCellular: A Phase III Randomized Double-Blind, Controlled Study of ICT-107 with Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma followingResection and Concomitant TMZ Chemoradiotherapy (NCT02546102)

Inspyr Therapeutics: Efficacy, Safety and CNS Exposure of G-202 in Patients with PSMA-Positive Recurrent or Progressive Glioblastoma (NCT02876003)

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 (NCT02616393)

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

 

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, najee.boucher@providence.org, 310-582-7460
Jaya M. Gill, RN., BSN, jaya.gill@providence.org, 310-582-7437
Annie Heng, RN, BSN, HengA@jwci.org, 310-582-7457
Tiffany Juarez, PhD, tiffany.juarez@jwci.org, 310-449-5225
Anand Moses, CRA, MosesA@jwci.org, 310-582-7097
Hanh Nguyen, CRA, NguyenThuyH@jwci.org, 310-582-7434
Michelle Phillips, Michelle.Phillips@providence.org, 310-582-7486                                                                                                                         

For more information, please explore the hyperlinks or contact the Neuro-Oncology Clinical Trial Team at:
e-mail: neuro.oncology@jwci.org  |  phone: 310-829-8265