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
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
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
EpiCentRX (NCT 02215512):
Dose-Escalation Study of RRx-001 in Combination With Whole Brain Radiation in Subjects With Brain Metastases (BRAINSTORM). Download pdf flyer
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 email@example.com or 310-829-8265.
About the Author
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.
Last updated: November 13th, 2019