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A Phase III, International, Randomized, Controlled Study of Rigosertib Versus Physician's Choice of Treatment in Patients With Myelodysplastic Syndrome After Failure of a Hypomethylating Agent
Onconova Therapeutics, Inc.
This is a Phase III, open label, randomised, controlled international study. There are approximately 100 sites.
Inclusion of approximately 225 patients who are less than 80 years of age with MDS classified as RAEB-1, RAEB-2, or RAEB-t who received AZA or DEC for 9 months and had their last dose within 6 months prior to screening.
Patients will be stratified by:
Very high risk (VHR) vs. non-VHR per IPSS-R,
Geographic region (North America vs. Europe vs. Asia) and randomly assigned in a 2:1 ratio into two treatment groups.
The two groups are as follows:
1. Rigosertib 1800 mg / 24 hr administered as a 72 hr CIV infusion on Days 1, 2 and 3, on a 2 week cycle for the first 8 cycles, and on days 1, 2, and 3 on a 4 week cycle thereafter (N = approximately 150 patients).
2. Physician's choice of alternative treatment, which may include any approved or standard of care therapy based on frequently used treatment for MDS after receipt of HMA's (N = approximately 75 patients). No experimental therapies are allowed on this arm.
Patients will be treated until 2006 IG progression criteria are met or until an unacceptable level of toxicity or intolerance.
For all radnomised patients who discontinue study treatment, subsequent therapies will be documented until death.
Patients in the PC group will not be allowed to cross-over to the Rigosertib group.
All patients will be allowed, as medically justified, access to RBC and platelet transfusions and growth factors.