Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA (INSPIRE) | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02562443

Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA (INSPIRE)
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

The primary objective of this study is to compare the overall survival (OS) of patients receiving intravenous (IV) rigosertib to the OS of patients receiving the physician's choice of treatment (PC) in a population of patients with myelodysplastic syndrome (MDS) after failure of treatment with a hypomethylating agent (HMA), azacitidine (AZA) or decitabine (DEC).

Status: 
Recruiting
Study Date: 
Fri, 10/02/2015 to Fri, 06/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Drug: rigosertib Patients will receive intravenous rigosertib 1800 mg/24 hr for 3 days every 2 weeks for first 8 cycles, then every 4 weeks thereafter + best supportive care (BSC). Other Name: ON 01910.Na Drug: Any approved or standard-of-care therapy Patients will receive Physician's Choice of Treatment or alternative treatment which may include any approved or standard-of-care therapy, based on frequently used treatment for MDS (no experimental therapy) + best supportive care.