Phase I/II Study of BNC105P in Combination with Everolimus or Following Everolimus for Progressive Metastatic Clear Cell Renal Cell Carcinoma Following Prior Tyrosine Kinase Inhibitors Hoosier Oncology Group GU09-145
Synopsis:
This is a Phase 2, double blind, randomized study, to be conducted in an outpatient setting.
The purpose of this research study is to test a new cancer treatment drug called BNC105P in combination with Everolimus to see what effects (good and bad) it has on you and your cancer.
The study drug, BNC105P, is made by Bionomics, a biotech company in Australia, and is an experimental drug. BNC105P is a drug that causes changes in the lining of the blood vessels nourishing the tumor cells more than the lining of the blood vessels nourishing the normal cells. These changes in the lining of the blood vessels reduces blood flow to the tumor causing reduced blood supply/nourishment to the tumor resulting in death of the tumor cells and reduction of the tumor size. It is different from the other drugs in the market in a way that it shuts down tumor blood vessels “locking itself” inside the tumor where it acts on the tumor cells resulting in tumor cell death. BNC105P is not available for you to buy (“on the market”). It is only available in research studies for patients like you with your medical condition.
Everolimus has been approved by the Federal Drug Administration (FDA) and for the treatment of renal cancer following treatment with the chemotherapies such as Sutent or Sorafenib. BNP105P has not been approved for use by the FDA.
Subjects will be randomly assigned to treatment with a combination of daily Everolimus and BNC105P on days 1 and 8 of a 21 Day Cycle (Arm A) or daily treatment with Everolimus alone (Arm B). Treatment will continue until disease progression occurs or toxicity to the treatment medications is detected. Subjects in Arm B (Everolimus only) are eligible to begin treatment with BNC105P (up to 12, 21 Day Cycles) when disease progression occurs during Everolimus treatment.
Sponsor:
Bionomics in collaboration with the Hoosier Oncology Group
This study is currently recruiting participants.
For more information, go to: http://clinicaltrials.gov
Study Contact:
Kellie Ritari, RN
Tel: 352-265-8285
Principal Investigator:
Dr. Long Dang
