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August 15, 2016

Clinical Trials Round-Up: August 2016

by Zara Jethani

We have added two new clinical trials to our roster.

NEW CLINICAL TRIALS

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

This study seeks to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide (TMZ) prolongs progression free survival (PFS) and overall survival (OS) in participants with newly diagnosed glioblastoma (GBM) with epidermal growth factor receptor (EGFR) amplification.

ABT-414 is an antibody drug conjugate (ADC) designed for the treatment of tumors harboring amplified genomic EGFR. Antibody drug conjugates are a rapidly growing class of cancer drugs that combine the targeting properties of monoclonal antibodies (mAbs) with the anti-tumor effects of potent cytotoxic drugs. Download pdf flyer

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.

This is a multi-center, open-label, Phase 2 trial of abemaciclib in patients with brain metastases secondary to HR+breast cancer, NSCLC, or melanoma. This study will evaluate the safety and efficacy of abemaciclib in patients with HR+metastatic breast cancer, NSCLC, or melanoma and new or not previously irradiated brain lesions as well as previously irradiated progressive brain lesions.

Abemaciclib (LY2835219) is an oral, selective, and potent small molecule inhibitor of cyclin-dependent kinase (CDK) 4 and 6 (CDK4 and CDK6) with acceptable physical characteristics, pharmacokinetic (PK) properties, and safety profile in nonclinical species. Download pdf flyer

Stages of brain tumor clinical trials
Source: ipmgl

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 Metastases. Download pdf flyer

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.

About the Author

Zara Jethani, MS, MBA

Zara Jethani

Zara is the marketing director at Pacific Neuroscience Institute. Her background is in molecular genetics research and healthcare marketing. In addition, she is a graphic designer with more than 20 years experience in the healthcare, education and entertainment industries.

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Last updated: November 13th, 2019