A Phase 2, Open-Label, Prospective Study of PRM-151 in Subjects with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocythemia MF (post-ET MF)
ID Number 13-1807Principal Investigator(s)
John O Mascarenhas
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to gather information on whether PRM-151 has an effect on your myelofibrosis (MF) disease, whether it is safe in patients with MF, and how well it is tolerated (that is, whether or not it makes you feel ill.) Blood samples will be taken to test how long PRM-151 stays in your blood and at what levels, and what changes, if any, PRM-151 causes in certain substances in your blood known as biomarkers.
PRM-151 is an investigational drug that is being developed for possible use in the treatment of myelofibrosis (MF). An investigational drug is one that has not been approved for use yet by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA). In this consent form, the study drug will be referred to as PRM-151.
This study drug has been tested in three clinical studies. In the first study, PRM-151 was given as a single intravenous dose, which means it was administered into a vein, to healthy volunteers and patients with idiopathic pulmonary fibrosis (IPF), a disease in which fibrosis in the lungs makes it difficult to breathe. It was found to be safe at doses of 0.1 milligrams per kilogram of body weight (mg/kg) to 20 mg/kg. In the second study, subjects with IPF received PRM-151 five times intravenously over 15 days and it was found to be safe at doses of 1, 5 and 10 mg/kg. In the third study, 61 patients with glaucoma were given 5 injections of PRM-151 in the eye and the drug was found to be safe when given this way too.
Recruiting Patients: Yes