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PNI Clinical Trials
December 19, 2018

Clinical Trials Round Up: December 2018

by Mini Gill

New Studies 

Spectrum Pharmaceuticals (PDF):An Open-label, Nonrandomized, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Belinostat in Patients with Relapsed/Refractory Solid Tumors or Hematological Malignancies Who Have Wild-Type, Heterozygous, and Homozygous UGT1A1*28 Genotypes (NCT03276268

The purpose of this research study is to determine the pharmacokinetic profile and safety of belinostat in patients with wild-type, heterozygous, and homozygous UGT1A1*28 genotypes. Inhibition of HDAC is expected to have utility in the treat-ment of diseases characterized by aberrant cellular division such as cancer.

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)

The purpose of this study is to assess the safety profile and response rate of isatuximab in combination with atezolizumab in participants with advanced malignancies such as glioblastoma (GBM), squamous cell carcinoma of head and neck (SCCHCC), hepatocellular carcinoma (HCC), and epithelial ovarian cancer (EOC).

Insyte (PDF): To examine the current disease progression of Parkinson’s disease psychosis (PDP), the clinical, economic, and humanistic impact of anti-psychotic therapy in the management of the condition in real-world settings, and the burden of the condition on patients and their caregivers (NCT03152292).

Cala PROSPECT (PDF): This is an open-label study of the Cala TWO device with home usage for 3 months to assess for duration of effect over the course of the trial. The device is a non-invasive peripheral neurostimulator for essential tremor and the study is open to patients with mild, moderate, and severe essential tremor.

NoNO, Inc. ESCAPE NA-1 : The ESCAPE-NA-1 study is designed to determine the safety and efficacy of the neuroprotectant, NA-1, in reducing global disability in subjects with major acute ischemic stroke (AIS) with a small established infarct core and with good collateral circulation who are selected for endovascular revascularization (NCT02930018).

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)

Aivita Biomedical (PDF):Phase II trial of AV-GBM-1 (autologous dendritic cells loaded with autologous tumor associated antigens) as an adjunctive therapy following primary surgery plus concurrent chemoradiation in patients with Newly-Diagnosed Glioblastoma Multiforme (GBM) (NCT03276268

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)

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

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


SanBio, Inc.: 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: 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.



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 following Resection 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)



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

Clinical Trials Team:

Jaya M. Gill, RN., BSN,, 310-582-7437
Annie Heng, RN, BSN,, 310-582-7457
Tiffany Juarez, PhD,, 310-449-5225
Anand Moses, CRA,, 310-582-7097
Hanh Nguyen, CRA,, 310-582-7434
Michelle Phillips,, 310-582-7486                                                                                                                         

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

About the Author

Jaya Mini Gill, RN, BSN

Mini Gill

Jaya Mini Gill, RN, BSN is involved in all aspects of clinical trial study design and processes in the Department of Translational Neurosciences and Neurotherapeutics at the Saint John’s Cancer Institute. An experienced nurse, she is responsible for accurate protocol implementation along with the treatment, care, management, and follow-up of patients.

Last updated: May 27th, 2020