Phase I/II, Multi-center, Dose-escalating Study of the Tolerability, Pharmacokinetics, and Clinical Activity of the Combined Administration of Oral Rigosertib with Azacitidine in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia
ID Number 13-1318Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to evaluate the tolerability and effectiveness of an oral formulation of Rigosertib combined with Azacitidine (Vidaza®) in treating your condition and to find the best
Version A, B
Page 2 of 14 IRB approved from 23Jul2013 through 21Jan2014.
regimen of Rigosertib that can be given safely.
Rigosertib is an experimental compound currently being tested in other clinical studies. An experimental drug is not approved by the United States Food and Drug Administration (FDA) for use except in research studies. Although the mechanism of action of Rigosertib is not fully known, it is thought to kill cancer cells by two different actions: it stops the tumor cells from dividing and growing, and blocks the proteins involved in cell division causing cells to die. Early information about the potential beneficial effects of this oral drug in patients with MDS is encouraging. A few patients were able achieve transfusion independence.
Azacitidine is already approved for the treatment of MDS.
There are two phases to this study.
• The purpose of the first phase is to evaluate the safety and find the best dose of oral Rigosertib combined with Azacitidine (Vidaza®).
• If a safe and effective dose of oral Rigosertib combined with Azacitidine (Vidaza®) is found then Phase two will start. The purpose of the second phase is to determine how well the dose of oral Rigosertib combined with Azacitidine (Vidaza®) found in the first phase works.
Recruiting Patients: Yes