Clinical Trials Round-Up: November 2016
by Zara Jethani
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.
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
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
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 firstname.lastname@example.org 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