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INSPIRE (NCT02562443), a Phase 3 clinical trial for patients with myelodysplastic syndromes (MDS), following hypomethylating agent (HMA) treatment failure, is open for enrollment in the United States, Europe, Australia, and Asia.
Myelodysplastic syndromes (MDS) are a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells. MDS is often referred to as a bone marrow failure disorder and may progress into acute myeloid leukemia (AML).
This Phase 3, randomized, controlled, international study is investigating the effectiveness of rigosertib, a small molecule that inhibits cellular signaling in cancer cells. One of the key aims of this international study is to determine the effectiveness of rigosertib compared to physician’s choice of treatment in extending the lives of patients. The study will enroll approximately 225 patients with MDS diagnosed via bone marrow analysis. Patients with higher-risk MDS between 18-81 years of age who failed the standard of care, called HMAs, are eligible for the trial. There are a number of other eligibility criteria that need to be met in order to participate in this study. As part of the pre-screening process, patients will be given advanced medical check-ups including bone marrow analysis and blood tests. Rigosertib therapy will be compared to physician's choice of treatment which may include standard of care therapy and best supportive care.
To date, more than 500 MDS patients have been enrolled in clinical trials with rigosertib.
All experimental treatment and study mandated medical assessments in the trial will be provided free of charge, and all participant details are kept confidential.
This research study has been approved by the relevant Government health authorities, and medical Ethics Committees.
For more information about the INSPIRE study see ClinicalTrials.Gov https://clinicaltrials.gov/ct2/show/NCT02562443