Clinical Trials Round-Up: May 2016

We have a number of ongoing and new clinical trials at the Pacific Brain Tumor Center for patients who may benefit from newer brain tumor treatment options. In our Clinical Trials Round-Up blog series, we will periodically provide an update on the latest clinical trials and studies at our center.

This month we announce the opening of a Phase 2 trial of tesevatinib in patients with non-small cell lung cancer (NSCLC) and leptomeningeal metastases or metastatic brain tumors.

Tyrosine kinases are important biomediators in the body and while their activity is tightly regulated in normal cells, they may acquire transforming functions due to mutation(s), leading to malignancy. Developed by biophamaceutical company Kadmon, tesevatinib is an oral tyrosine kinase inhibitor (TKI) designed to block key molecular drivers of tumor growth, metastases and drug resistance. Unlike other TKIs, tesevatinib crosses the blood-brain barrier, which separates the circulating blood from the brain. Preclinical and early clinical studies have shown tesevatinib’s activity against epidermal growth factor receptor (EGFR), a cell surface receptor, and its accumulation in the lungs, leptomeninges (membranes that protect the brain and spinal cord) and kidneys. The Phase 2 clinical trial at our center represents an ongoing study of tesevatinib in patients with NSCLC with activating EGFR mutations and brain metastases or leptomeningeal disease.

NEW CLINICAL TRIAL

NSCLC and brain or leptomeningeal metastases
Kadmon (NCT 02616393):
A Phase 2, Multicenter 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. Download pdf flyer

ACTIVELY RECRUITING TRIALS

Glioblastoma
Triphase (NCT 02330562):
Study of Marizomib in Bevacizumab-Naïve Subjects with WHO Grade IV Malignant Glioma. Download pdf flyer

Nativis (NCT 02296580):
A Feasibility Study of the Nativis Voyager System in Patients With Recurrent Glioblastoma Multiforme (GBM). Download pdf flyer 

Brain Metastasis

EpiCentRX (NCT 02215512):
Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases (BRAINSTORM). Download pdf flyer

Investigators:
Garni Barkhoudarian, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Steven O’Day, MD

Clinical Trial Team:
Marlon Garzo Saria, MSN, RN, AOCNS, FAAN  |  310-582-7340
Annie Heng, RN, BSN   |  310-582-7457
Najee Boucher, CRA  |  310-582-7460

If you or your physician are considering entering into a study, please review full details of each of our clinical trials. For more information, contact the Clinical Trial Team at neuro.oncology@jwci.org or 310-829-8265.