Open label study of single agent oral RG7388 in patients with polycythemia vera and essential thrombocythemia, with pilot feasibility study in combination with pegylated interferon alfa 2a

ID Number 14-1919

Principal Investigator(s)
John O Mascarenhas

Department(s) or Division(s)
Hematology and Medical Oncology

Description

The research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV).  ET causes people to produce too many blood cells called platelets and pV causes too many platelets and red blood cells to be made.  Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising.  Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes.  When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increase the risk of developing blood clots.

The purpose of Part A of this study is to see if the study drug RG7388 is safe and able to be tolerated by patients and identify the dose to use for future research studies.  We want to find out what effects, good and/or bad it has on you and your disease.

The purpose of Part B of this study is to see if the combination of RG7388 and Pegylated Interferon Alfa-2a or Pegasys in PV/ET patients from Part A is safe and able to be tolerated for those who did not have a partial response to just receiving the RG7388 study drug.



Contact Information
Jill Kleczko
(212) 241-0573

Recruiting Patients: Yes