PNIBLOG

Clinical Trials Round Up September 2016

We are pleased to announce a new clinical trial protocol that is now available at the Pacific Neuroscience Research Center at PNI.

NEW CLINICAL TRIAL

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

Glioblastoma (GBM) comprises about 16% of all malignancies of the nervous system and over 50% of all gliomas. Standard of care for newly-diagnosed GBM and gliomas is a combination of surgical debulking followed by concurrent radiotherapy and chemotherapy with temozolomide. Efforts to improve second-line therapy in GBM have met with only marginal success and there is a large unmet medical need for new therapies.

Prodrug chemotherapy is an approach to cancer treatment that is being investigated as a means to achieve higher concentrations of cytotoxic or biologically active agents at a tumor location while avoiding systemic toxicity. G-202 is an example of prodrug chemotherapy. It is activated by Prostate Specific Membrane Antigen (PSMA), which is expressed by some cancer cells and in the blood vessels of most solid tumors, including GBM, but not by normal cells or blood vessels in normal tissue. It is believed that activation of the prodrug G-202 will allow the drug to kill cancer cells. This study will evaluate the activity, safety and CNS exposure of G- 202 in patients with PSMA-positive recurrent or progressive GBM receiving G-202 by intravenous infusion on three consecutive days of a 28-day cycle. Download pdf flyer

ACTIVELY RECRUITING TRIALS

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 MetastasesDownload pdf flyer

Glioblastoma

AbbVie / RTOG (NCT 02573324):
A Study of ABT-414 in Subjects With Newly Diagnosed Glioblastoma (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.