A Phase 2 Pilot Trial of Ruxolitinib combined with Danazol for Patients with Primary Myelofibrosis (MF), Post Essential Thrombocythemia-Myelofibrosis (Post ET) and Post Polycythemia Vera Myelofibrosis (PV MF) Suffering from Anemia
ID Number 13-0277Principal Investigator(s)
John O Mascarenhas
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to find out if the drug Ruxolitnib combined with Danazol is safe and has beneficial effects in people who are diagnosed with Primary Myelofibrosis (PMF) or Post-Essential Thromobocythemia Myelofibrosis (PET MF) or Post-Polycythemia Vera Myelofibrosis (PPV MF) and have anemia, low red blood cell count, below 10g/dL as a consequence of their disease.
So far, over 200 healthy subjects and about 600 people with primary Myelofibrosis, Post-Polycythemia Vera- Myelofibrosis and Post-Essential Thrombocythemia-Myelofibrosis have been tested with Ruxolitinib in other clinical trials. In all those trials, Ruxolitinib has been given at several different dose levels, both higher and lower than the dose levels that will be used in this study.
Ruxolitinib is approved by the FDA for treating patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. Danazol is not FDA approved for this indication although it has been studied as a single agent in this setting. The combination for the two has not yet been studied.
The primary purpose of this study is to determine the effects of Ruxolitinib combined with Danazol on anemia and symptoms and to learn about any of the side effects that might occur during or following dosing. This study will also help us determine the appropriate dosing for people with low platelets.
You are being asked to take part in this research study because you have been diagnosed as having Primary Myelofibrosis (PV MF), Post Essential Thrombocythemia-Myelofibrosis (Post ET) or Post Polycythemia Vera Myelofibrosis (PV MF) and are suffering from Anemia. Funds for conducting this research are provided by Incyte Corporation.
Recruiting Patients: Yes