Clinical Trials Round-Up: November 2016

We have recently added a new clinical trial protocol at the Pacific Neuroscience Research Center at PNI.

NEW CLINICAL TRIAL

Boehringer Ingelheim (NCT 02423525):
A Phase I Dose Escalation and CNS Pharmacokinetic Study of the ErbB Family Inhibitor Afatinib in Patients with Recurrent or Progressive Brain Cancer.

This study is a Phase I dose escalation and CNS pharmacokinetic study of the ErbB family inhibitor afatinib in patients with recurrent or progressive brain cancer. It is an open-label, single institution, 3+3 dose escalation study to describe the safety and tolerability of afatinib in patients with brain cancer having failed prior therapy and to determine the recommended phase II dose.

Eligible patients will receive afatinib in treatment cycles of 28 days that will consist of afatinib administered orally by mouth once every four days. Patients will be assigned to the dose level open at the time of their enrollment. Patients will continue dosing of afatinib until disease progression, unacceptable toxicity, withdrawal of consent, or treating physician determines it is in their best interest to stop.

Afatinib (BIBW2992; Gilotrif®) is a small molecule, selective and irreversible ErbB family blocker. In preclinical models it effectively inhibits EGFR, HER2 and HER4 phosphorylation resulting in tumor growth inhibition and regression of established subcutaneous tumors derived from four human cell-lines known to co-express ErbB receptors. Download pdf flyer.

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

Glioblastoma

Inspyr Therapeutics (NCT 02876003):
Efficacy, Safety and CNS Exposure of G-202 in Patients with PSMA-Positive Recurrent or Progressive Glioblastoma. Download pdf flyer

AbbVie / RTOG (NCT 02573324):
A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma Multiforme (GBM) With Epidermal Growth Factor Receptor (EGFR) Amplification. Download pdf flyer

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

Eli Lilly and Company (NCT 02308020):
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. Download pdf flyer

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:
Achal S. Achrol, MD
Garni Barkhoudarian, MD
Daniel Kelly, MD
Santosh Kesari MD, PhD, FANA, FAAN
Steven O’Day, MD

Clinical Trial Team:
Najee Boucher, CRA  |  310-582-7460
Jaya M. Gill, RN, BSN  |  310-582-7437
Annie Heng, RN, BSN   |  310-582-7457
Marlon Garzo Saria, MSN, RN, AOCNS, FAAN  |  310-582-7340

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.